Download New Drug Approvals – 2007

New Drug Approvals – 2007
New Drug Approvals: 2007
Analysis: New drugs can contribute substantially to the year over year increases in drug spending. Benefit plans continue to
face two important and challenging goals: providing broad access to needed pharmaceuticals while at the same time trying to
contain the increasing costs of the prescription benefit. Therefore, the ability to discern significant innovations in drug development
from drugs that may offer only modest incremental health benefits is an important consideration for payors and health plans.
In 2007, the FDA approved a total of 16 new molecular entities (NMEs) and 7 therapeutic biologic, blood product, or vaccine
agents. This is one less than the 20-year low of only 17 NME approvals in 2002.
Listed below are approved new drugs, selected new combinations/formulations and important new indications for drugs approved
In 2007. Please Note: this list does not include all newly approved drugs.
How to use the data: Plan sponsors should keep well informed on new drug approvals as new drugs can contribute significantly to
drug trend. When considering new drugs it is important to differentiate between new drugs that could result in entirely new incremental
costs for a plan versus new drugs that will simply be more or less expensive replacements for existing drugs in the class. In other
words, some drugs could cause an expansion in utilization, e.g. Lyrica®, whereas other drugs will not dramatically expand utilization
but rather garner market share from existing drugs, e.g. Xyzal® and Vyvanse™. The information provided in the table below will be
updated regularly so that plan sponsors can remain informed about new drug introductions.
Source: FDC Pink Sheets; FDA Centers for Drug Evaluation and Research, FDA Center for Biological Evaluation and Research
New Drugs - 2007
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1 of 120
New Drug Approvals – 2007
New Drugs:
1. Luvox® (fluvoxamine)
2. BystolicTM (nebivolol)
3. Kuvan™ (sapropterin)
4. Mircera® (epoetin beta)
5. Doribax™ (doripenem)
6. Tasigna® (nilotinib)
7. Ixempra™ (ixabepilone)
8. Isentress™ (raltegravir)
9. Somatuline® Depot (lanreotide)
10. Selzentry™ (maraviroc)
11. Letairis™ (ambrisentan)
12. Nuvigil™ (armodafinil)
13. Torisel™ (temsirolimus)
14. Xyzal® (levocetirizine)
15. Perforomist™ (formoterol fumarate 20 mcg/2mL inhalation solution)
16. Neupro® (rotigotine transdermal patch)
17. AzaSite™ (azithromycin 1% ophthalmic solution)
18. Reclast® (zoledronic acid)
19. H5N1A avian influenza vaccine (pandemic influenza vaccine)
20. Altabax™ (retapamulin)
21. Ceprotin® (concentrated human protein C)
22. Soliris® (eculizumab)
23. Tykerb® (lapatinib)
24. Tekturna® (aliskiren)
25. Vyvase™ (lisdexamfetamine)
26. Lialda™ (mesalamine)
New Drugs - 2007
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2 of 120
New Drug Approvals – 2007
Selected New Indications:
1. Thyrogen® (thyrotropin alfa)
2. Diovan® (valsartan)
3. Cymbalta® (duloxetine)
4. Abilify® (aripiprazole)
5. Nexavar® (sorafenib)
6. Crestor® (rosuvastatin)
7. Menactra® (meningococcal polysaccharide diphtheria toxoid conjugate vaccine)
8. Januvia™ (sitagliptin)
9. Erbitux® (cetuximab)
10. Taxotere® (docetaxel)
11. Campath® (alemtuzumab)
12. Flumist® (cold adapted influenza vaccine, trivalent)
13. Levaquin® (levofloxacin)
14. Evista® (raloxifene)
15. Aloxi ® (palonosetron)
16. Risperdal® (risperidone)
17. Reclast® (zoledronic acid)
18. Lyrica™ (pregabalin)
19. Fragmin® (dalteparin)
20. Singulair® (montelukast)
21. Keppra® (levetiracetam)
22. Lipitor® (atorvastatin)
23. Humira® (adalimumab)
24. Cymbalta® (duloxetine)
25. Sutent® (sunitinib)
New Drugs - 2007
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New Drug Approvals – 2007
Selected New Combinations / Formulations:
1. Protonix® For Delayed-Release Oral Suspension (pantoprazole enteric coated granules)
2. Combigan™ (brimonidine / timolol ophthalmic solution)
3. Voltaren® Gel (diclofenac topical gel)
4. Renvela™ (sevelamer carbonate)
5. Hycamtin® (topotecan)
6. Lamisil® Oral Granules (terbinafine)
7. Azor™ (amlodipine/ olmesartan)
8. ACAM2000™ (smallpox vaccine)
9. Zingo™ (lidocaine powder)
10. LCP-FenoChol (fenofibrate)
11. Sanctura® XR (trospium)
12. Evamist™ (estradiol MDTS)
13. CaloMist™ (cyanocobalamin nasal spray)
14. Atralin™ (tretinoin 0.05% gel)
15. Allegra® ODT (fexofenadine)
16. Privigen™ (immune globulin intravenous (Human) 10%)
17. Exelon® patch (rivastigmine)
18. Exforge® (amlodipine / valsartan)
19. Endometrin® (progesterone vaginal inserts)
20. Lexiva® (fosamprenavir)
21. Extina® Foam 2% (ketoconazole)
22. Divigel® (estradiol 0.1% gel)
23. Zyflo CR™ (zileuton controlled-release)
24. Lybrel™ (levonorgestrel 0.09 mg/ethinyl estradiol 0.02 mg)
25. Locoid® (hydrocortisone butyrate lotion)
26. Seroquel® XR (quetiapine extended-release)
27. Supprelin®-LA (histrelin)
28. Lantus SoloStar® (Insulin glargine)
29. Veramyst™ (fluticasone furoate)
New Drugs - 2007
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New Drug Approvals – 2007
Selected New Combinations / Formulations: (continued)
30. Tovalt™ ODT (zolpidem ODT)
31. Enjuvia™ (synthetic conjugated estrogens)
32. Valtropin® (somatropin)
33. Actonel® (risedronate)
34. Risperdal® Consta® (risperidone depot)
35. Janumet® (sitagliptin/metformin)
36. Amrix® (cyclobenzaprine extended release)
37. Flector™ (diclofenac patch)
38. Olux-E™ (clobetasol 0.05% topical foam)
New Drugs - 2007
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5 of 120
New Drug Approvals – 2007
New Drugs:
Drug
Manufacturer
Route
Approval date
fluvoxamine
(Luvox®)
Solvay/Jazz
Oral
Approved:
12/20/07
nebivolol
(BystolicTM)
Mylan/Forest
Oral
Approved:
12/18/07
Indication
For the
treatment of
obsessive
compulsive
disorder
(OCD).
Therapeutic Considerations
Brand Luvox was removed from the market in 2002. This is a “re-approval”
and is for obsessive compulsive disorder (OCD).
Affected
Population
There are over 20
million Americans
in the US with
Solvay/Jazz stated they will not market this immediate release form. The
anxiety disorders.
company focus is on a CR form for future approval.
These include
panic disorder,
phobia and
obsessive
compulsive
disorder.
for the
Nebivolol is a once daily beta-adrenergic blocker. In extensive metabolizers
According to the
treatment of
(most of the population) and at doses ≤10mg, nebivolol is preferentially beta-1 Heart Disease
hypertension. selective. In poor metabolizers and at higher doses, nebivolol inhibits both
and Stroke
May be
receptors. It also has vasodilating properties.
Statistics 2006,
used alone or
nearly one in
in combination Efficacy:
three Americans
with other
The efficacy over 12 weeks as monotherapy was shown in 2 randomized,
suffers from
antihypertensiv double-blind, multi-center, placebo-controlled trials (n=1716) at doses of 1.25 elevated blood
e agents.
to 40mg for 12 weeks (Studies I and 2). A 3rd study evaluated nebivolol
pressure
monotherapy in 300 African-Americans with mild/moderate HTN. A 4th trial
(hypertension). An
demonstrated effects when administered with up to 2 other antihypertensives earlier study found
(ACE inhibitors, ARBs, and thiazide diuretics). The results are shown below: that only 29% of
those diagnosed
Placebo-subtracted Mean Reduction in Trough Systolic/Diastolic BP:
with hypertension
achieve adequate
Study 1and 2:
(N=300)
(N=669)
control (<140/90
(N=1716)
African American Combo Rx
mmHg) with
Dose
Study 1
Study 2
Study 3:
Study 4:
New Drugs - 2007
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Costs
(AWP)
Not
available
~$3.00 to
$3.50 per
day
6 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
5mg
-8.1/-5.5
-3.8/-3.2
-2.6/-4.9
-5.7/-3.3
10mg
-9.2/-6.3
-3.1/-3.9
-6/-6.1
-3.7/-3.5
20mg
-8.7/-6.9
-6.3/-4.5
-7.2/-6.1
-6.2/-4.6
30-40mg
-11.7/-8/3
NA
-6.8/-5.5
NA
All BP reductions were significant (p<0.05) in each study at each dosing level
with the exception of systolic pressures at the 5mg and 10mg dose in Study 2.
Safety:
Nebivolol is metabolized via CYP2D6. Caution is recommended if coadministered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine,
paroxetine, etc.) as they will significantly increase plasma levels of nebivolol.
Nebivolol is contraindicated in patients with severe renal or hepatic failure.
This agent carries all warnings that are associated with the prescribing of other
beta-blocking agents, including: exacerbation of ischemia or angina with
abrupt withdrawl; heart failure; bronchospastic disease; use during anesthesia;
diabetes and hypoglycemia; thyrotoxicosis; peripheral vascular disease; and
concomitant use with non-dihydropyricdine CCBs. Prescribing information
must be referred to regarding these warnings and the use of nebivolol.
In clinical trials nebivolol was well tolerated; the most common adverse events
compared to placebo respectively were: headacne (9% vs. 6%); fatigue (5%
vs. 1%); dizziness (4% vs. 1%); nausea (3% vs. 0) and diarrhea (3% vs. 2%).
Pregnancy Category C.
Affected
Population
Costs
(AWP)
treatment; nearly
half receive no
treatment at all.
Research shows
that patients cite
side effects as a
major reason for
not taking
medication.
Dosing: The dose is initiated at 5mg daily and can be increased at 2 week
intervals to a maximum dose of 40mg daily.
How Supplied: Available as tablets in the following strengths: 2.5mg, 5mg, and
10mg in bottles of 30 and 100 tablets requiring room temperature storage.
New Drugs - 2007
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7 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
sapropterin
(Kuvan™)
BioMarin
Oral
Approved:
12/13/07
Indication
Therapeutic Considerations
Sapropterin is
indicated to
reduce blood
phenylalanine
(Phe) levels
patients with
hyperphenylala
ninemia (HPA)
due to
tetrahydrobiopt
erin- (BH4-)
responsive
Phenylketonuri
a
(PKU).
Sapropterin is
to be used in
conjunction
with a Pherestricted diet
Sapropterin is a synthetic form of BH4, a naturally occurring enzyme cofactor.
Treatment results in activation of the enzyme phenylalanine hydroxylase
(PAH) to improve normal oxidative metabolism of Phenylalanine (Phe).
Therapy results in decreased Phe levels.
Efficacy:
Efficacy was established in 4 clinical trials. One trial was an 11-week multicenter double-blind, placebo controlled, Phase III study of sapropterin, with
diet, in 90 patients who were 4-12 years old with blood Phe ≤480 mmol/L.
Sapropterin therapy resulted in 56% of patients reaching the primary endpoint
(≥30% reduction in Phe vs. baseline (BL)).
Another trial consisted of 489 patients enrolled in an 8 day course of
sapropterin 10 mg/kg/day. Of the 489 patients; 20% responded with ≥30%
reduction in Phe vs. BL. A follow up trial was performed in 88 patients. In this
multicenter, double blind, placebo (PBO) controlled trial; 41 patients were
randomized to sapropterin and 47 to placebo. BL Phe in the sapropterin and
PBO groups were 843 ± 300 umol/L and 888 ± 323 umol/L respectively. After
6 weeks of therapy Phe levels fell to a mean of 607 ± 377 umol/L and 891±
348 umol/L respectively. (p< 0.0001 sapropterin vs. PBO).
In an open-label extension trial (n=80), doses of sapropterin 5, 10, and 20
mg/kg/day were evaluated. The primary endpoint was change in Phe vs. BL.
The following changes were reported after 6 weeks: 5mg/kg/day = -100 ± 295
umol/L; 10mg/kg/day = -204 ± 303 umol/L and 20mg/kg/day = -263 ± 318
umol/L.
New Drugs - 2007
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Affected
Population
Costs
(AWP)
PKU, a genetic
$29 per 100
disorder affecting mg tablet
at least 50,000
diagnosed
patients under the
age of 40 in the
developed world,
an estimated half
of whom have the
moderate to mild
form of the
disease, is caused
by a deficiency of
the enzyme,
phenylalanine
hydroxylase
(PAH). PAH is
required for the
metabolism of
Phe, an essential
amino acid found
in most proteincontaining foods.
If the active
enzyme is not
present in
sufficient
quantities, Phe
accumulates to
8 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Safety:
The most common adverse events (≥5%) in patients treated with Sapropterin
vs. placebo were: headache (15% vs. 14%), diarrhea (8% vs. 5%), vomiting
(8% vs. 5%), upper respiratory tract infection (12% vs. 24%), and
pharyngolaryngeal pain (10% vs. 2%). Pregnancy Category: C. Women who
are exposed to Sapropterin during pregnancy are encouraged to enroll in the
Sapropterin patient registry. No drug interaction studies have been performed
however, caution is advised with use of sapropterin in conjunction with drugs
that affect folate metabolism (MTX), levodopa, and PDE-5 inhibitors (i.e.:
sildenafil or vardenafil) due to toxicities that may result.
abnormally high
levels in the blood
and brain
resulting in a
variety of
complications,
including severe
mental retardation
and brain
damage, mental
illness, seizures
and tremors, and
cognitive
problems.
Dosing:
The starting dose is 10mg/kg/day taken once daily with food. Doses may be
adjusted in the range of 5 to 20 mg/kg. Blood Phe must be monitored
regularly. Dose is dissolved in 4-8oz. of water or apple juice and taken within
15 minutes.
Costs
(AWP)
How Supplied:
Available as 100mg tablets in bottles of 120 tablets requiring room
temperature storage. This agent is included in the Medco Accredo Specialty
program.
epoetin beta
(Mircera®)
Hoffman/
LaRoche
For anemia
with chronic
kidney disease
(CKD or CRF)
in patients on
dialysis and not
on dialysis
This new erythropoetin (ESA) is not indicated for anemia due to chemotherapy
at this time. The agent will likely not be available for some time (estimated
2012) due to an ongoing patent case will determine when patients can gain
access.
Efficacy:
The efficacy was assessed in 6 open-label, multi-center clinical studies that
New Drugs - 2007
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Anemia is an
important
complication of
kidney disease
and is usually
treated when it
falls below 10
Not
available
9 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Injectable
Indication
Approved:
11/14/07
Therapeutic Considerations
Affected
Population
randomized patients to this agent or a comparator ESA. Two studies
evaluated anemic patients with CRF who were not treated with an ESA at
baseline. After 28 weeks (study 1), the % of patients requiring RBC
transfusion was 2.5% in the epoetin beta group vs. 6.8% in the comparator
(darbepoetin) and after 24 weeks (study 2), 5.2% in the epoetin beta group vs.
4.3% in the epoetin alfa group. Four studies evaluated patients who were
receiving an ESA for treatment of anemia of CRF. Treatment with epoetin
beta once every two weeks and once every four weeks maintained
hemoglobin concentrations within the targeted hemoglobin range (10 to 13.5
g/dL).
.
Safety:
Like other erythropoietin agents, this drug carries a black box warning
regarding increased mortality, serious cardiovascular and thromboembolic
events, and tumor progression. Other features of its safety profile are well
established and similar to other erythropoetins.
g/dL. According
to the US Renal
Data System, a
federally funded
organization that
collects data on
the treatment of
patients with
kidney disease,
most dialysis
patients receive
treatment for
anemia. About
half of dialysis
patients have a
hemoglobin level
above 12 g/dL
and about 20%
have levels higher
than 13 g/dL
Dosing: 0.6 mcglkg administered IV or SC once every two weeks.
How Supplied: Not available at this time.
doripenem
(Doribax™)
J&J
injection – IV
For the
treatment of
complicated
intra-abdominal
and
complicated
urinary tract
infections.
Doripenem is a carbapenem antibacterial agent. Doripenem shares the
bactericidal mechanism of action of other β-lactams by targeting penicillinbinding proteins (PBPs) to inhibit the biosynthesis of the bacterial cell wall.
Antibiotics approved for complicated intra-abdominal infections include Tygacil
(tigecycline) and Merrem (meropenem).
Antimicrobial activity:
Activity against both Gram(-) and Gram(+) bacteria and superior activity to
New Drugs - 2007
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© 2004-2008 Medco Health Solutions, Inc. All rights reserved.
Costs
(AWP)
About 3.5 million $47.91 per
cases of
vial
complicated intraabdominal
infections are
reported in the US
each year.
10 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Approved:
10/13/07
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
meropenem and imipenem against Pseudomonas aeruginosa. The compound Pyelonephritis is a
is stable to most β-lactamases.
potentially organand/or lifeEfficacy:
threatening
The approval of doripenem for complicated intra-abdominal infections was
infection that may
based on 2 multicenter, double-blind trials enrolling 946 patients. The trials
lead to multiorgan
compared doripenem 500mg q8h to meropenem 1gm q8h for 5 to 14 days
failure.
total. Doripenem was non-inferior to meropenem with regard to clinical cure
The frequency in
rate. The approval in complicated urinary tract infections was based on 2
preschool girls is
multicenter trials in 1,171 adult patients. One trial was a randomized, double- <2%; pregnant
blind comparative trial evaluating doripenem (500mg IV q8h) and levofloxacin women, 2-9.5%;
(250mg IV q24h). Doripenem was non-inferior to levofloxacin.
women aged 6580 years, 18-43%;
Safety:
men aged 65-80
Most common adverse events (≥ 5%) vs. comparator were: headache (4-16% years, 1.5-15.3%;
vs. 5-15%), nausea (4-12% vs. 6-9%), diarrhea (6-11% vs. 10-11%), rash (1- in women >80
5% vs. 1-2%), and anemia (2-10% vs. 1-5%). Caution is advised regarding
years, 18-43%;
administration with valproic acid (reduced valproate concentrations) and
and in men >80
probenecid (increased doripenem concentrations). Pregnancy Category B.
years, 5.4-21%.
More than
Dosing: 500 mg q8h IV over one hour; adjusted based on renal function.
250,000 cases
occur in the US
How Supplied: 500mg vial requiring room temperature storage. This agent is each year, and
not currently part of the Medco Accredo Specialty programs.
~200,000 require
hospitalization.
New Drugs - 2007
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Tasigna®
(nilotinib)
Novartis
Oral
Approved:
10/29/07
Indication
For treatment
of chronicphase and
acceleratedphase Ph+
CML in adult
patients
resistant or
intolerant to
prior treatment,
including
imatinib
(Gleevec).
Therapeutic Considerations
Nilotinib works by inhibiting the proliferation of cells containing an abnormal
chromosome by targeting the production of the Bcr-Abl protein. In preclinical
studies, the drug was able to overcome resistance resulting from Bcr- Abl
kinase mutations in 32 of 33 cell lines commonly associated with Ph+ CML.
Efficacy:
Approval was based on a multicenter trial evaluating safety and rates of
cytogenetic response (i.e. reduction or elimination of the Ph+ chromosome)
and hematologic response (i.e. normalization of white blood cell counts) in
Glivec-resistant or -intolerant patients with Ph+ CML in chronic phase (n=280)
and accelerated phase (n=105). The primary endpoint for patients in chronic
phase was unconfirmed major cytogenetic response (MCyR). After a median
duration of 8.7 mos, Tasigna produced MCyR in 40% of 232 chronic phase
patients evaluated for efficacy. The complete cytogenetic response in these
patients was 28%. For patients in accelerated phase, the primary endpoint
was confirmed hematological response (HR). Complete HR was reported in
18% of patients. (minimum follow-up = 4 mos; median treatment duration = 6.4
mos). The highest prior imatinib dose was at least 600mg/day in 77% of
patients, with 44% of patients receiving doses of ≥800mg/day. In addition, 24
different mutations in Bcr-Abl were noted in 19% of chronic phase and 25% of
accelerated phase CML patients who were evaluated for mutations.
Affected
Population
Costs
(AWP)
CML is one of the $59.39 per
200mg
four most
common types of capsule
leukemia, a form
of blood cancer,
and affects
around 4,500
people in the US
each year.
Without treatment,
CML typically
progresses over
3-5 years from the
initial (chronic)
phase through a
transition period
(accelerated
phase) to a rapidly
fatal form (blast
crisis).
Safety:
Nilotinib carries a black box warning regaring prolongation of the QTc interval
and factors that may increase this risk such as hypokalemia,
hypomagnesemia, use with CYP3A4 inhibitors, and hepatic impairment. The
most frequent adverse events were hematological and included neutropenia
and thrombocytopenia. Transient elevations were seen in bilirubin, liver
function tests, lipase enzymes and blood sugar. Pancreatitis was reported in
New Drugs - 2007
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
<1%. The most frequent non-hematologic adverse events were rash, pruritus,
nausea, fatigue, headache, constipation, and diarrhea. Caution should be
used in patients with significant cardiac disease.
Nilotinib is a competitive inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6
and UGT1A1. Caution should be exercised when co-administering nilotinib
with substrates that have a narrow therapeutic index. Warfarin should be
avoided. Nilotinib may induce CYP2B6, CYP2C8 and CYP2C9. If nilotinib is
administered with drugs that are substrates of Pgp, increased concentrations
of the substrate drug are likely. Pregnancy Category: D.
Dosing: 400mg (2 capsules) orally twice daily, approximately 12 hours apart.
No food should be consumed for 2 hours prior to a dose or 1 hour after the
dose is taken.
How Supplied: 200mg caps in blister packs of 28; requiring room temperature
storage.
Ixempra™
(Ixabepilone)
BMS
IV injection
Approved:
10/16/07
For the
treatment of
metastatic or
locally
advanced
breast cancer
as combination
therapy with
capecitabine in
patients after
failure of an
Ixabepilone is an anti-neoplastic drug with a mechanism of action similar to the The National
taxanes. The manufacturer is co-developing response-predicting biomarkers Cancer Institute
with the drug, but has not disclosed the identity of those biomarkers of interest. estimates that that
about one in eight
Efficacy:
women in the U.S.
In an open-label, multicenter trial, patients with metastatic or locally advanced (approx. 13%) will
breast cancer were randomized to ixabepilone (40mg/m2 every 3 weeks for a develop breast
median of 5 cycles) plus capecitabine (1000 mg/m2 BID for 2 weeks followed cancer during her
by 1 week rest) (n= 375) or capecitabine alone (1250 mg/m2 BID for 2 weeks lifetime.
followed by 1 week rest for a median of 4 cycles) (n=377). Patients were
previously treated with, and demonstrated tumor progression or resistance to,
New Drugs - 2007
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$1,153 per
15mg vial;
$3,457 per
45mg vial
13 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
anthracycline
and a taxane,
or as
monotherapy in
patients after
failure of an
anthracycline, a
taxane, and
capecitabine.
anthracyclines and taxanes. The primary endpoint of the study was
progression-free survival (PFS). Ixabepilone plus capecitabine resulted in a
significant improvement in PFS compared to capecitabine (5.7 months vs. 4.1
months, respectively) (p<0.0001).
Affected
Population
Costs
(AWP)
Efficacy as a single agent was demonstrated in a multicenter single-arm study.
Women (n=126) with metastatic or locally advanced breast cancer with
recurring tumors or tumors that had progressed following ≥2 chemotherapy
regimens including an anthracycline, a taxane, and capecitabine were
enrolled. Ixabepilone was administered at a dose of 40 mg/m2 IV for a
median of 4 cycles. The objective tumor response (by investigators) was
18.3%, median time to response was 6.1 weeks and median duration of
response 6 months.
Safety:
Ixabepilone carries a black box warning regarding the potential for toxicity and
neutropenia-related death when administered in combination with capecitabine
in patients with hepatic impairment. The most common adverse reactions
(≥20%) are peripheral sensory neuropathy, fatigue/asthenia,
myalgia/arthralgia, alopecia, nausea,
vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. Additional
events in ≥20% in combination treatment include: palmar-plantar
erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, and
constipation. Hematologic events (>40%) include neutropenia, leukopenia,
anemia, and thrombocytopenia. Inhibitors of CYP3A4 may increase
concentrations of ixabepilone and inducers may decrease concentrations.
Pregnancy Category: D.
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
An estimated 40
million people are
currently infected
worldwide with
HIV, and it is
estimated that
more than four
million new
infections occur
worldwide
annually. AIDS is
one of the top
causes of
infectious
disease-related
mortality
worldwide,
responsible for
WAC of $27
per day
Dosing:
40 mg/m2 IV over 3 hours every 3 weeks. Dose reduction is required in
patients with elevated AST, ALT, or bilirubin. Must premedicate all patients
with an H1and H2 antagonist before treatment. Procedures for proper handling
and disposal of antineoplastic drugs should be followed.
How Supplied:
15 mg vial supplied with 8 mL diluent and 45 mg supplied with 23.5 mL diluent
requiring refrigerated storage. This agent may be included in the Medco
Specialty Offering.
Isentress™
(raltegravir)
Merck
Oral
Approved:
10/12/07
In combination
with other
antiretroviral
agents for the
treatment of
HIV-1 infection
in treatmentexperienced
adult patients
who have
evidence of
viral replication
and HIV-1
strains resistant
to multiple
antiretroviral
agents.
Raltegravir is a human immunodeficiency virus integrase strand transfer
inhibitor (HIV-1 INSTI) or “integrase inhibitor” that belongs to a new class of
antiretroviral therapy (ART) agents. Integrase inhibitors inhibit the insertion of
the HIV viral DNA into human DNA. Integrase is one of three HIV enzymes reverse transcriptase, protease and integrase - required by the virus to
reproduce.
Efficacy:
The efficacy is based on a data from two 24-week ongoing, double-blind,
placebo-controlled trials, BENCHMRK 1 and BENCHMRK 2. Patients were
randomized to raltegravir 400mg twice daily plus optimized background
therapy (OBT) (n=462) or OBT alone (n=237). Patients had documented
resistance to at least 1 drug in each of 3 Classes (NNRTIs, NRTIs, PIs) of
antiretroviral therapies. At 24 weeks, HIV-1 RNA results were < 400
copies/mL in 75.5% of patients treated with raltegravir/OBT vs. 39.3% of
those treated with OBT alone. HIV-1 RNA was < 50 copies/mL in 62.6% and
33.3% respectively. Confirmed virologic failure was reported in 16% of
patients treated with raltegravir/OBT vs. 51.1% treated with OBT alone.
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$16.87 per
tablet
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
Safety:
approximately
The most common adverse events (>10%) of all intensities,
three million
reported in subjects in either the raltegravir/OBT or the OBT alone group,
deaths each year.
regardless of causality were: nausea (9.9% vs. 14.2%), headache (9.7% vs.
11.7%), diarrhea (16.6% vs. 19.5%) and pyrexia (4.9% vs. 10.3%). Increases
in serum glucose, aspartate and alanine aminotransferase, lipase and creatine
kinase were observed more commonly in patients treated with raltegravir/OBT
compared to OBT alone. In combination with strong inducers of uridine
diphosphate glucuronosyltransferase (UGT) 1A1 (e.g., rifampin) raltegravir
exposure will be reduced. Pregnancy Category: C.
Dosing: 400 mg administered orally, twice daily with or without food.
How Supplied: 400mg tablets in bottles of 60 requiring room temperature
storage.
Somatuline®
Depot
(lanreotide)
Tercica/IPSEN
Injection
Approved:
8/30/07
-For the long
term treatment
of acromegalic
patients who
have had an
inadequate
response to or
cannot be
treated with
or/surgery and
radiotherapy
Lanreotide is an analog of octreotide (Sandostatin). This formulation releases
lanreotide over 28-56 days. In acromegaly, lanreotide is used primarily when
circulating levels of growth hormone (GH) are high despite surgery or
radiotherapy.
Acromegaly is a
disorder caused
by the overproduction of
growth hormone
®
The FDA granted lanreotide (Ipstyl ) orphan drug status for acromegaly Sept. secondary to a
11, 2000. Lanreotide is marketed in 51 countries, for treatment of
benign tumor of
neuroendocrine tumours (particularly of a carcinoid type). Lanreotide received the anterior
an approvable letter in 2001 from the FDA for neuroendocrine tumours.
pituitary gland.
Acromegaly
Efficacy:
affects
Three clinical trials provided information regarding the efficacy of lanreotide.
approximately
An open-label multicenter study in 92 patients with acromegaly showed that IM 15,000 people in
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$2,137.50
per 60mg;
$2,585.00
per 90mg;
$3,821.25
per 120mg
16 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
lanreotide (60mg every 28 days x 3 followed by dosing based on growth
hormone (GH)) maintained GH< 2.5 mcg/L and insulin-like growth factor-1
(IGF-1) in normal range. At the end of therapy (median, 24 mos), IGF-1
decreased from 199 ± 8% (% of the ULN, mean ± SE) to 87 ± 4% (p < 0.0001)
in 65% of patients treated. GH fell to < 2.5 mcg/L in 63% (p<0.0001).
the US and
Canada and is
most commonly
found in middleaged adults.
Studies estimate
an all-cause
mortality rate
associated with
acromegaly of at
least twice the
normal
population, and a
reduction in life
expectancy of 5 to
10 years.
In 124 patients with acromegaly, lanreotide depot for 1 year was more
effective than lanreotide 30mg (non-sustained release formulation) in the
control of GH hypersecretion. The % of patients achieving control of GH
levels was 42% with depot and 32% with the original formulation.
Eight patients had normalized GH and IGF-1 levels after receiving lanreotide
depot for 28 weeks in a multicenter study in 12 (10 completed) patients with
acromegaly. Patients received 20mg octreotide LAR for > 4 months before
being switched to lanreotide depot at doses of 90mg (n=5), 60mg (n=2) and
120mg (n=3).
Costs
(AWP)
Safety:
Adverse events reported include mild to moderate gastrointestinal events
(abdominal pain-19%, nausea-11%, steatorrhea-7%, diarrhea-37%),
musculoskeletal pain (9%), and injection-site symptoms (9%). Gallstones
occur; in one study, sludge or stones were detected in 11%. There were no
clinically significant changes in vital signs or biochemical/hematological
parameters detected. Pregnancy Category: C.
Dosing:
The starting dose is 90 mg given via deep SC, at 4 week intervals for 3
months. After 3 months the dose should be adjusted according to the
response of the patient as judged by a reduction in serum GH and /or IGF-1
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
levels; and/or changes in symptoms of acromegaly.
How Supplied:
60mg, 90mg and 120mg single use pre-filled syringes requiring refrigeration.
It is unknown at this time if there is a limited distribution program.
Selzentry™
(maraviroc)
Pfizer
Oral
Priority review
Approved:
8/6/07
In combination
with other
antiretroviral
agents, for
treatmentexperienced
adult patients
infected with
only CCR5tropic HIV-1
detectable
virus, who have
evidence of
viral replication
and HIV-1
strains resistant
to multiple
antiretroviral
agents.
Maraviroc is a CCR5 antagonist. CCR5, a cell-surface G protein coupled
receptor, has been identified as the principal co-receptor along with CD4
through which, macrophage tropic HIV-1 strains gain entry into host cells. In
preclinical studies, maraviroc demonstrated potency against CCR5 isolates,
but not against CXCR4 virus. Labeling contains information suggesting
confirmation of CCR5-tropism status before using maraviroc.
HIV infects
approximately 1.7
million people in
North America
and Western
Europe and
approximately 40
Efficacy:
million people
The efficacy of maraviroc was established in analyses of 24-week data from
worldwide. CCR5two multicenter, randomized, double-blind, placebo-controlled ongoing studies, tropic strains are
MOTIVATE-1 and MOTIVATE-2.
most frequently
transmitted.
In the MOTIVATE 1 and 2 trials, antiretroviral treatment-experienced adults
Approximately
infected with CCR5-tropic HIV-1 were randomized to maraviroc 300mg daily or 650,000 patients
BID (n=426), or placebo (n=209). All patients continued an optimized
are treated
background therapy of antiretroviral agents. After 24 weeks, the % of patients annually for HIV in
with HIV-1 RNA <400 copies/mL receiving maraviroc vs. placebo was 61%
the United States
and 28%, respectively. The mean changes in plasma HIV-1 RNA from
and Western
baseline to week 24 was –1.96 log10 copies/mL for subjects receiving
Europe.
maraviroc vs. –0.99 log10 copies/mL for subjects receiving placebo. The
Resistance to
mean increase in CD4+ counts was higher on maraviroc twice daily (106.3
currently available
cells/mm3) vs. placebo (57.4 cells/mm3).
drugs is one of
the most pressing
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$1,087.50
per 60
tablets at
any
strength.
$36.25 per
day.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Safety:
There are no efficacy or safety data available in treatment-naïve adult patients
or pediatric patients <16 years old. Maraviroc carries a black box warning
regarding potential hepatotoxicity which may be preceded by systemic allergic
signs/symptoms. Cardiovascular events including myocardial ischemia and/or
infarction were observed in clinical trials. Postural hypotension has been
reported in patients with a history of postural hypotension or who receive
concomitant medication known to lower blood pressure. Immune
reconstitution syndrome has been reported in patients treated with
combination antiretroviral therapy, including maraviroc. In clinical trials, the
most common adverse events with frequency rates higher than placebo
(>8%), regardless of causality, were cough, pyrexia, upper respiratory tract
infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.
Pregnancy category: B.
Affected
Population
Costs
(AWP)
problems in HIV
therapy and the
leading cause of
treatment failure.
Dosing:
150mg, 300mg or 600mg twice daily with or without food. Dose is dependent
on the CYP3A4 induction/inhibition status of concomitant antiviral therapy.
How Supplied:
50mg and 300mg tablets in bottles of 60 requiring room temperature storage.
The shelf life is 24 months.
Letairis™
(Ambrisentan)
Oral
For pulmonary
arterial
hypertension
(PAH)
in patients with
WHO
An endothelin receptor antagonist (ETA) indicated for less severe PAH.
Letairis is selective for endothelin A where as Tracleer® (bosentan)
antagonizes both endothelin receptor type A and type B.
Efficacy:
The efficacy of ambrisentan once daily for PAH was based on 2 pivotal trials;
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PAH is a rare and
potentially fatal
disease. It is
characterized by
abnormally high
blood pressures in
$3,940 for a
one-month
supply, or
30-tablet
pack
19 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Myogen/Gilead
Priority review
Approved:
6/15/07
Indication
Functional
Class II or III
symptoms to
improve
exercise
capacity and
delay clinical
worsening.
Therapeutic Considerations
Affected
Population
Costs
(AWP)
ARIES-1 & ARIES-2. The randomized, double-blind, placebo-controlled, 12
week trials enrolled 393 patients. ARIES-1 evaluated 5mg (n=67) or 10mg
(n=67). ARIES-2 evaluated doses of 2.5mg (n=64) or 5mg (n=63). The primary
endpoint was change from baseline in the six-minute walk test vs placebo. In
ARIES-1, the mean change in the test with ambrisentan 5mg, 10mg was 23 +/83 and 44 +/- 63 respectively vs placebo -8 +/-79 (p<0.01). In AIRES-2 the
mean change in the test with ambrisentan 2.5mg, 5mg was 22 +/- 83 and 49
+/- 75 respectively vs placebo -10 +/- 94 (p<0.05). Secondary endpoints,
including time to worsening, SF-36 Health Survey, and Borg dyspnea index,
demonstrated significant improvements with ambrisentan vs placebo
the arteries
connecting the
lungs with the
heart. Patients
with PAH often
become short of
breath after
physical exertion
and the disease
leads to heart
failure. PAH
Safety:
affects two people
Ambrisentan carries a Black box warning regarding elevations of liver tests
in ten thousand
(ALT, AST) and serious liver injury. The drug is Pregnancy Category: X.
but is two to three
Pregnancy must be excluded prior to therapy and pregnancy should be
times more
prevented by two methods. In clinical trials the most common adverse events common in
were edema (6%), nasal congestion (4%), sinusitis (3%), flushing (3%),
women than men
palpitations (3%), abdominal pain (2%), and constipation (2%). Decreases in and often strikes
hemoglobin (>15% decline) have been observed in up to 10% of patients.
women during
There are significant drug interactions with this agent; refer to product labeling. their child-bearing
years. Left
Dosage: 5 mg once daily with or without food; dose may be increased to 10mg untreated, PAH
daily. Tablets should not be split, crushed, or chewed.
will significantly
reduce life
How Supplied: 5mg and 10mg tablets in quantities of 30 requiring room
expectancy.
temperature storage. Ambrisentan is available only through a restricted
distribution program: Letairis Education and Access Program (LEAP). Letairis
may be dispensed only to patients who are enrolled in and meet all conditions
of LEAP.
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Approval date
Nuvigil™
(armodafinil)
Cephalon
Oral
Approved:
6/15/07
Indication
To improve
wakefulness in
patients
suffering from
excessive
sleepiness
associated with
narcolepsy,
shift work sleep
disorder
(SWSD) and
obstructive
sleep
apnea/hypopne
a syndrome
(OSA/HS).
In OSAHS,
armodafinil is
indicated as an
adjunct to
standard
treatment(s) for
the underlying
obstruction.
Therapeutic Considerations
Affected
Population
Costs
(AWP)
Armodafinil is the R-isomer of modafinil (Provigil) which is a mixture of the Rand S-enantiomers. Armodafinil is a Schedule IV controlled substance. This
agent may not be marketed until the patent of Provigil expires in 2012.
Excessive
$5 - $7 per
sleepiness is the day
primary symptom
- and often the
Efficacy:
most debilitating
Efficacy was established in four, 12-week, placebo-controlled trials in patients feature - patients
with narcolepsy (N=196), OSA/HS (2 trials; total N=658) or SWSD (N=254). In experience with
the OSAHS trial, patients were required to continue and be compliant with
OSA/HS, SWSD
CPAP. The primary endpoints were measures of objective sleep latency
and narcolepsy.
(Maintenance of Wakefulness Test or Multiple Sleep Latency Test) and the
Associated with a
physician rating of Clinical Global Impression-Change. Patients treated with
reduction of
armodafinil significantly improved the primary endpoints vs. placebo.
activity in the
cerebral cortex of
Results: Avg. Change vs. Baseline - Sleep Latency Test (minutes)
the brain, the
Study
Test
Change from Baseline
defining
150mg
250mg
Placebo
characteristic of
OSAHS-1
MWT
1.7
2.2
- 1.7
excessive
OSAHS-2
MWT
2.3
NA
- 1.3
sleepiness is a
Narcolepsy
MWT
1.3
2.6
- 1.9
consistent inability
SWSD
MSLT
3.1
NA
0.4
to stay awake and
All comparisons; p<0.05; NA: dose not assessed
alert enough to
safely and
Results: % Improved: Clinical Global Impression of Change (CGI-C)
successfully
Study
150mg
250mg
Placebo
accomplish tasks
OSAHS-1
71%
74%
37%
of daily living.
OSAHS-2
71%
NA
53%
While millions of
Narcolepsy
69%
73%
33%
Americans suffer
SWSD
79%
NA
59%
from narcolepsy,
All comparisons; p<0.05; NA: dose not assessed
OSA/HS and
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Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
Safety:
Benign rashes can occur with armodafinil, some may be serious. Armodafinil
should be discontinued at the first sign of rash. Discontinuation of treatment
may not prevent a rash from becoming life-threatening. In clinical trials, the
only adverse events that appeared to be dose related were headache (17%),
rash (2%), depression (2%), dry mouth (4%), insomnia (5%), and nausea
(7%). Pregnancy Category: C.
SWSD, they are
often
misdiagnosed and
underdiagnosis
has been
estimated to be
between 50-90%.
Persons
Dosage: OSAHS and Narcolepsy: 150mg or 250mg as a single dose in the experiencing
morning. In patients with OSAHS there is no consistent evidence that this
excessive
dose doses up to 250 mg/day confer additional benefit beyond that of the 150 sleepiness
mg/day dose. SWSD: 150 mg given daily ~1 hour prior to the start of their
typically complain
work shift. Dose adjustment is required with certain drugs due to interactions; of fatigue, lapses
please refer to product labeling.
of attention,
disrupted sleep,
How Supplied: Available as 50, 150, and 250mg tablets in bottles of 60 tablets or difficulties at
requiring room temperature storage.
work.
Torisel™
(temsirolimus)
Wyeth
Intravenous
Approved:
5/30/07
For advanced
renal cell
carcinoma
(RCC)
Renal cell
$1,441.00
carcinoma
per kit
accounts for
about 85% of all
renal cancers.
Globally, more
than 208,000 new
Efficacy:
cases of kidney
A phase III, 3- arm study compared temsirolimus in combination with
cancer were
interferon, and interferon alone in patients with metastatic RCC. Overall
diagnosed in 2002
survival for the 3 arms was 10.9, 8.4, and 7.3 months, respectively. At the time -- including about
Temsirolimus, an mTORI inhibitor is the major metabolite is sirolimus
(Rapamune®). mTOR inhibition blocks translation of genes that regulate the
cell cycle and results in reduced cell growth factors involved in development of
new blood vessels, such as vascular endothelial growth factor. Temsirolimus is
the first targeted renal cancer therapy proven to extend survival vs. interferonalpha.
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Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
of the interim analysis, there were 442 deaths in the 626-patient study.
Compared with interferon alone, treatment with single agent temsirolimus
resulted in a 49% improvement in median overall survival and a reduced
hazard ratio for death of 0.73. Temsirolimus/interferon combination was
associated with a 15% increase in median survival and a reduction in the
hazard ratio for death relative to interferon.
36,700 in the US - according to
estimates from the
International
Agency for
Research on
Cancer (IARC),
Safety:
part of the World
The most common adverse events (≥ 30%) are rash, asthenia, mucositis,
Health
nausea, edema, and anorexia. The most common laboratory abnormalities
Organization
(≥30%) are anemia, hyperglycemia, hyperlipemia, hypertriglyceridemia,
(WHO). The
elevated alk. phosphatase, elevated serum creatinine, lymphopenia,
incidence of the
hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.
disease is highest
Pregnancy category: D. Other reported events: hypersensitivity reactions,
among people
increases in serum glucose, triglycerides and cholesterol, immunosuppression, between the ages
interstitial lung disease (some resulting in death), bowel perforation, and renal of 50 to 70, and it
failure. Due to abnormal wound healing, use with caution in the perioperative affects nearly
period. Patients with central nervous system tumors (primary CNS tumor or
twice as many
metastases) and/or receiving anticoagulation therapy may be at a high risk of men as women.
intracerebral bleeding.
Approximately
Dosing: 25mg I.V. once a week until disease progression or unacceptable
25% with RCC are
toxicity. Antihistamine pre-treatment is recommended.
initially diagnosed
with advanced
How Supplied: 25 mg/mL vial supplied with diluent. The two vials are supplied disease. Patients
as a kit to be stored at 2°-8°C (36°-46°F). There is no special distribution
with advanced
program at this time.
RCC have a fiveyear survival rate
of ~ 20%.
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Drug
Manufacturer
Route
Approval date
Xyzal®
(levocetirizine)
UCB/SanofiAventis
Oral
Approved:
5/25/07
Indication
Therapeutic Considerations
For the relief of
symptoms
associated with
seasonal (SAR)
and perennial
allergic rhinitis
(PAR) and for
the treatment of
uncomplicated
skin
manifestations
of chronic
urticaria (CIU)
in adults and
children six
years of age
and older.
Levocetirizine is a single isomer form of the histamine H1 antagonist cetirizine.
Cetirizine is the active ingredient in Zyrtec. In Zyrtec, cetrizine exists in two
forms; the levocetirizine isomer and the dexcetirizine isomer. Xyzal contains
only levocetirizine. Zyrtec is available OTC.
Efficacy:
Efficacy was evaluated in 6 randomized, placebo-controlled, double-blind trials
in 2412 patients aged 12 years and older: one 2-week trial in SAR, and 2 trials
in PAR. Efficacy was assessed using a patient total symptom score (TSS)
based on 4 or 5 symptoms: sneezing, rhinorrhea, nasal pruritus, ocular
pruritus and/or nasal congestion. The primary endpoint was the mean TSS
over 2 weeks for SAR trials, and 4 weeks for PAR trials. Levocetirizine 5mg
demonstrated a significant decrease in TSS from baseline vs placebo. The
efficacy in CIU was evaluated in 2 multi-center, randomized, placebocontrolled, double-blind trials over 4 weeks in 423 patients. Efficacy was
based on patient recording of pruritus severity using a score of 0–3 (0 = none
to 3 = severe). The primary efficacy endpoint was the mean score over the first
week and entire treatment period. Levocetirizine demonstrated a significant
decrease from baseline in the score vs placebo. Duration of pruritus, number
and size of wheals also showed significant improvement over placebo.
Safety:
The most common (≥ 2%) adverse events in patients aged 12 years and older
were nasopharyngitis, somnolence, fatigue, and dry mouth. In children 6 to 12
years old, pyrexia, cough, somnolence, and epistaxis were more commonly
reported. Most adverse events were considered mild to moderate.
Dosing: Once a day in the evening as follows: Persons >12 years of age: 5
mg (1 tablet); children 6 to 11 years of age: 2.5 mg (1/2 tablet). Adjust the
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Affected
Population
Costs
(AWP)
Seasonal Allergic ~$2-3 per
Rhinitis (SAR),
day
commonly
referred to as "hay
fever" or "outdoor
allergies," is the
most common
form of allergic
rhinitis. Perennial
Allergic Rhinitis
(PAR) is often
referred to as
"year round" and
is characterized
by allergies that
last longer than
four weeks.
House dust mites,
animal dander,
and mold most
commonly trigger
PAR. Chronic
Idiopathic
Urticaria (CIU) is
most commonly
known as "hives
of unknown origin"
and is defined as
the occurrence of
24 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
dose in patients 12 years of age and older with decreased renal function.
How supplied:
5mg tablets (scored) in bottles of 30 and 180 tablets and 3 blister cards of 10
tablets each, stored at room temperature.
Perforomist™
(formoterol
fumarate 20
mcg/2mL)
Dey
Inhalation
solution
Approved:
5/11/07
For the longterm, twicedaily
maintenance
treatment of
bronchoconstriction in
patients with
chronic
obstructive
pulmonary
disease
Formoterol is a beta2 agonist that has been previously approved in the U.S. as
a dry powder; the molecule has 20 years of worldwide use. Perforomist™
Solution is the first and only nebulized formoterol fumarate. Perforomist will
compete with arformoterol (Brovana™).
Efficacy:
The evaluations of Perforomist included two clinical trials involving 1,045
patients. In the pivotal trial, 351 patients with COPD participated in a 12-week,
multi-center study. Patients were treated with Perforomist 20 mcg/2 mL twice
daily (n=123); formoterol powder (Foradil®) (n=114), or placebo (n=114).
Perforomist 20 mcg/2 mL taken twice daily was superior to placebo for the
primary endpoint, FEV1 AUC 0-12.
Safety:
The safety profile observed in this study was comparable to that of Foradil®.
Additionally, patients treated with Perforomist used less rescue albuterol
during the trial compared to patients treated with placebo.
Dosing: 20mcg/2 ml by inhalation every 12 hours.
How supplied: Unit dose vials of 20mcg/2ml requiring refrigerated storage.
After dispensing, it may be stored up to 77 degrees F for up to 3 months.
New Drugs - 2007
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Affected
Population
Costs
(AWP)
daily, or almost
daily, wheals and
itching for at least
6 weeks with no
obvious causes.
The most
$5.81 per
common forms of package
COPD are chronic
bronchitis and
emphysema.
COPD is the 4th
leading cause of
death in the US.
The most
common cause of
COPD is cigarette
use, which is
responsible for an
estimated 80% of
COPD cases.
Estimates of the
total incidence of
COPD range from
24 to 30 million
persons.
25 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Neupro®
(rotigotine)
Schwarz
Pharma
transdermal
patch
Approved:
5/9/07
Indication
For treatment
of early-stage
Parkinson’s
disease (PD).
Therapeutic Considerations
Rotigotine is a dopamine agonist available in a once-daily transdermal patch
for treatment of early Parkinson's disease. Currently available oral dopamine
agonists (Ie., Mirapex, Permax, Requip) are usually given three times a day.
Efficacy:
Efficacy was proven in 277 early stage, idiopathic PD patients assigned
Neupro or placebo for up to 28 weeks. Patients underwent a weekly titration (2
mg/24hours dose change at weekly intervals) over 3 weeks to a max dose of 6
mg/24 hours and then received therapy for 24 weeks followed by deescalation over 4 days. Approximately 90% of patients randomized to Neupro
achieved a max dose of 6 mg/24 hours; 70% maintained this dose for most (>
20 weeks) of the maintenance phase. Most patients (> 81%) completed
treatment. The primary efficacy endpoint was change in UPDRS (measures
ability to perform basic motor skills and daily living activities). Neupro treated
patients experienced a significant change in UPDRS from baseline to end of
treatment (-4.0) vs placebo (+1.39).
Affected
Population
Costs
(AWP)
In the United
$4-5 per day
States, it is
estimated that
60,000 new cases
are diagnosed
each year, joining
the 1.5 million
Americans who
currently have
Parkinson
disease. While
the condition
usually develops
after the age of
65, 15% of those
diagnosed are
under 50.
Safety:
Approximately 13% discontinued treatment vs 6% with placebo. The adverse
events most commonly causing discontinuation of treatment were: application
site reaction (5% vs 0% on placebo), nausea (2% vs 0% on placebo), and
vomiting (1% vs 0% on placebo).
Dosing: Dosing is initiated at 2mg/24hours. Based upon response and
tolerability, the dose may be increased weekly by 2mg/24hours. The lowest
effective dose was 4mg/24hours; the highest = 6mg/24hours. If it is necessary
to discontinue use, the daily dose should be reduced by 2mg/24 hours with
dose reduction preferably every other day, until complete withdrawal.
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26 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
How Supplied: Available in doses of 2mg, 4mg and 6mg patches in cartons
containing 7 and 30 patches requiring room temperature storage.
AzaSite™
For the
treatment of
(azithromycin
bacterial
1%)
conjunctivitis
caused by the
Ophthalmic
following
solution
organisms:
CDC
Inspire
coryneform
Pharmaceuticals group G,
, Inc.
Staphylococcus aureus,
Approved:
Streptococcus
4/27/07
pneumoniae,
and
Haemophilus
influenzae.
AzaSite is azithromycin ophthalmic solution formulated in DuraSite®, an ocular
drug delivery system. It will compete with Ocuflox® (ofloxacin) and Ciloxan®
(ciprofloxacin) which are available as generics. The dosing range for these
available alternatives is four times a day to every 4 hours.
Efficacy:
In a randomized, vehicle-controlled, double-blind, multicenter study,
azithromycin was dosed twice daily for the first two days, then once daily on
days 3, 4, and 5. Azithromycin 1% solution was superior to vehicle on days 67 in patients who had a confirmed clinical diagnosis of bacterial conjunctivitis.
Clinical resolution was achieved in 63% (82/130) of patients treated with
azithromycin versus 50% (74/149) treated with vehicle. (p= 0.03; CI was 2% to
25%). The microbiological success rate for the eradication of the baseline
pathogens was 88% vs 66% with vehicle (p<.001, CI was 13% to 31%).
Safety: The most common adverse event was eye irritation, which occurred in
1-2% of patients. Pregnancy category B.
Dosing: One drop twice-a-day for two days, followed by one drop once-a-day
for the next five days, for a total of nine drops in the affected eye.
How Supplied: 5 mL size bottle filled with 2.5 mL of 1% sterile topical
ophthalmic solution. Store unopened bottle under refrigeration at 2°C to 8°C
(36°F to 46°F). Once the bottle is opened, store at 2°C to 25°C (36°F to 77°F)
for up to 14 days. Discard after the 14 days.
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Bacterial
$66.25 per
conjunctivitis is a bottle
common eye
infection
characterized by
inflammation of
the mucous
membranes of the
eyes and the
eyelids. The
infection, which is
common in
children, may be
contagious and is
accompanied by
irritation, itching,
and redness. The
common bacteria
associated with
acute
conjunctivitis are
Haemophilus
influenzae, Strep.
pnuemoniae, and
Staph species.
27 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Reclast®
Indication
For Paget's
disease of
(zoledronic acid) bone.
Novartis
IV infusion
Approved:
4/17/07
Therapeutic Considerations
A bisphosphonate agent for Paget's disease. Reclast is the same ingredient
found in Zometa® which is used for hypercalcemia of malignancy. Reclast will
compete with oral therapies such as Actonel® (risedronate) and Fosamax®
(alendronate) that must be taken daily for several months or Aredia®
(pamidronate) that requires three IV infusions.
Efficacy:
The efficacy of Reclast 5mg vs risedronate 30mg daily (oral) for 2 months was
demonstrated in two randomized, double blind trials in patients with moderate
to severe Paget’s disease. Therapeutic response was defined as either
normalization of serum alkaline phosphatase (SAP) or reduction (>75%) in
total SAP excess vs. baseline at 6 months. The 6-month data from both trials
showed 96% (169/176) of zoledronic acid-treated patients achieved a
response vs. 74% (127/171) treated with risedronate. At 6 months, 89%
(156/176) zoledronic acid-treated patients achieved normal SAP levels, vs.
58% (99/171) treated with risedronate (p<0.0001). In patients who had
previously received oral bisphosphonates, response rates were 96% and 55%
for zoledronic acid and risedronate, respectively. In patients naïve to
treatment, a greater response was also observed with zoledronic acid (98%)
vs. risedronate (86%). In patients with symptomatic pain at screening,
response rates were 94% and 70% for zoledronic acid and risedronate
respectively. For patients without pain, response rates were 100% and 82%
for zoledronic acid and risedronate, respectively.
Safety:
Side effects include: fever and chills; muscle, bone or joint pain; nausea;
fatigue; and headache. Most are mild and occur within 3 days after dosing.
Zoledronic acid may cause hypocalcemia. It is not recommended in renal
impairment (CrCL <35mL/min). Osteonecrosis of the jaw has been reported in
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Affected
Population
Costs
(AWP)
Approximately
$1,302 per
one million people vial
in the US have
Paget’s disease of
bone. Paget’s
disease is a
chronic, skeletal
disorder
characterized by
greatly increased
and disorderly
bone remodeling.
Clinical
manifestations of
Paget’s disease
range from no
symptoms to
severe morbidity
due to bone pain,
bone deformity,
pathological
fractures, and
other
complications.
Serum alkaline
phosphatase,
provides an
objective measure
of disease
28 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
patients treated with bisphosphonates including zoledronic acid. Pregnancy
Category D.
Affected
Population
Costs
(AWP)
severity and
response to
therapy.
Dosing:
5 mg / 100 mL IV one time. To reduce hypocalcemia, patients should receive
1500 mg calcium and 800 IU vit. D daily, particularly 2 weeks following first
dose. Re-treatment may be considered in patients who have relapsed, failed,
or in patients with symptoms.
How supplied:
A solution containing 5 mg zoledronic acid in 100mL requiring room
temperature storage. After the vial is opened, it is stable for 24 hours under
refrigeration.
H5N1A avian
influenza
vaccine
(pandemic
influenza
vaccine)
Sanofi
Injection
Approved:
4/17/07
For
immunization of
people 18
through 64
years of age
who could be at
increased risk
of exposure to
the H5N1
influenza virus
contained in
the vaccine
Obtained from a human strain of H5N1 influenza virus.
Efficacy:
A total of 103 healthy adults received a 90 mcg followed by another 90 mcg
dose 28 days later. Approximately 300 healthy adults received doses lower
than 90 mcg and a total of 48 received placebo. The study showed that 45%
who received the 90 mcg, two-dose regimen developed antibodies at a level
that is expected to reduce the risk of getting influenza. Although the level of
antibodies seen in the remaining individuals did not reach that level, current
scientific information on other influenza vaccines suggests that less than
optimal antibody levels may still have the potential to help reduce disease
severity and influenza-related hospitalizations and deaths. Additional
information on this H5N1 influenza vaccine is being collected on safety and
effectiveness in other age groups and will be available to FDA in the near
future.
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The H5N1 virus is Not
one version of the available
influenza A virus
commonly found
in birds. While
there have been
no reported
human cases of
H5N1 in the US,
almost 300 people
worldwide have
been infected
since 2003 and
more than half
died. To date,
29 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
According to a March 2006 FDA draft guidance, developmental pandemic
vaccines intended for individuals ≤65 years of age must meet at least one of
two efficacy criteria to receive accelerated approval: either the percent of
subjects achieving seroconversion of HI antibodies should meet or exceed
40%, or the % of subjects achieving an HIA titer of ≥1:40 should meet or
exceed 70%. However, in a Phase III clinical study funded by NIH, the
vaccine failed to statistically meet either criteria, with 45.1% (95% CI: 34.6%55.8%) of participants achieving HIA seroconversion 28 days post-vaccination
and 46% (95% CI: 35.6%-56.9%) of participants achieving an HIA titer of
>1:40.
H5N1 influenza
has remained
primarily an
animal disease
but should the
virus acquire the
ability for
sustained
transmission
among humans,
people will have
little immunity to
this virus and the
potential for an
influenza
pandemic would
have grave
consequences for
global public
health.
Safety: The most common side effects reported were pain at injection site,
headache, general ill feeling and muscle pain.
Dosing: Each dose is 90 mcg. Two doses are given as IM injections, given
approximately one month apart.
How Supplied:
The vaccine will not be sold commercially; it is part of the U.S. Strategic
National Stockpile for distribution by public health officials if needed.
Altabax™
For the topical
treatment of
(retapamulin)
impetigo due to
Staph aureus
GlaxoSmithKline (methicillin
sensitive only)
Topical
or Strep
pyogenes
A member of a new class of antibacterials known as pleuromutilins that have a
low propensity for developing bacterial resistance. Shown in-vitro to have
excellent activity against gram-positive organisms, including strains that are
resistant to existing antimicrobials. Altabax will compete with mupirocin
(Centany® or Bactroban®).
Impetigo is a
common and
contagious
bacterial skin
infection, which
reportedly has a
Efficacy:
high rate of
In a phase III, randomized, placebo-controlled study in impetigo, 7-day clinical spontaneous
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Costs
(AWP)
5gm = $41
10gm =
$69.50
15gm = $85
30 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Approved:
4/12/07
Indication
isolates in
patients aged 9
months or
older.
Therapeutic Considerations
Affected
Population
Costs
(AWP)
success was reported in 86% of those treated with retapamulin (n=139) vs
resolution.
52% treated with placebo (n=71). Microbiologic success was reported in 91%
vs. 51% respectively. Study participants were treated twice daily for 5 days.
Only 6% of patients in the treatment group, compared with 38% in the placebo
group, withdrew because of disease progression or lack of efficacy. In another
trial retapamulin twice daily (n=345) proved at least as effective as 2% fusidic
acid ointment (n=172) applied three times daily for 7 days. Clinical success at
the end of treatment was 99% vs. 94% respectively. Microbiologic success
was also comparable, at 98% and 94%, respectively. (Fusidic acid is not
approved in the US).
Safety: The most common treatment-related adverse event was applicationsite pruritus, which occurred in 7% of patients. Pregnancy Category B. The
safety and effectiveness in patients younger than 9 months have not been
established.
Dosing: Applied twice daily for 5 days.
How Supplied: 5 gram, 10 gram, and 15 gram tubes. Store at 25°C (77°F) with
excursions permitted to 15°-30°C (59°-86°).
Ceprotin®
(concentrated
human Protein
C)
Baxter
Healthcare
For severe
congenital
Protein C
deficiency
Ceprotin (a concentrated form of Protein C, a substance normally manufactured
in the liver that circulates in the plasma) is made from the plasma of human
blood donors. Protein C plays a role in preventing formation and growth of
blood clots.
Efficacy:
Efficacy was based on a multicenter, open-label, non-randomized study in 18
patients ranging from newborn to 25 years. Ceprotin was effective in 94% of
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Severe congenital $1.44 per
Protein C
unit
deficiency is a
rare genetic
defect found in
one to two
newborns for
every million
31 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Injection
Approved:
3/30/07
Indication
Therapeutic Considerations
episodes. When compared with efficacy of 21 episodes of PF treated with
Fresh Frozen Plasma or conventional anticoagulants, patients were more
effectively treated with Ceprotin.
Safety: No serious reactions to Ceprotin have been reported. The most
common reactions were rash, itching and lightheadedness. Other reported
reactions were hemothorax, hypotension, hyperhydrosis, fever and
restlessness. The agent contains trace quantities of heparin.
Dosing: Dosing will vary based on the needs of the patient. Dosing used in
some trials was 10 U/kg/h (to target protein C activity 100%) or as bolus
infusions (100 U/kg every 6 h). Patients may be instructed on self
administration.
How Supplied: As 500 IU per vial and 1000 IU per vial in powder form for
reconstitution with sterile water requiring refrigeration at 2°C to 8°C (36°F to
46°F).
Soliris®
(eculizumab)
Alexion
Intravenous
Approved:
3/16/07
For the
treatment of
Paroxysmal
Nocturnal
Hemoglobinuria
("PNH").
Eculizumab, a monoclonal antibody, functions as a long-acting complement
inhibitor. It blocks progression of the complement cascade which destroys
abnormal red blood cells.
Efficacy:
The efficacy was evaluated in TRIUMPH, a phase III, randomized, multicenter,
double-blind, placebo-controlled trial in 87 patients conducted over 6 months.
Patients were randomized to eculizumab 600 mg weekly for 4 weeks, followed
one week later by 900 mg and then 900 mg every other week through week 26
or placebo. The two primary end points were stabilization of hemoglobin
(Hbg) levels and number of units of packed red cells transfused. At 26 weeks,
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Affected
Population
births. The
condition results
in an abnormal
tendency for
blood clotting.
This can cause
severe, often lifethreatening clots
in small blood
vessels. The clots
can lead to
blindness, brain
damage, multiorgan failure and
death. Currently
there are fewer
than 20 known
cases in the U.S.
PNH is a blood
disorder
characterized by
the onset of
severe anemia,
chronic fatigue
and intermittent
episodes of dark
colored urine,
known as
hemoglobinuria.
Costs
(AWP)
$4,992 per
300 mg vial,
with patients
receiving 78
vials, or 26
treatments,
per year
32 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
49% in the eculizumab group (21/32) had Hbg levels above baseline in the
absence of transfusions, vs. 0 in the placebo group (p < .001). The median
number of units of red cells transfused per patient was 0 in the eculizumab
group vs. 10 for placebo (p < .001). The median time to transfusion was
significantly longer in patients treated with eculizumab vs. placebo (p <.001).
Tykerb®
(lapatinib)
Oral
GSK
Approved:
For use in
combination
with Xeloda, for
the treatment of
advanced or
metastatic
HER2 (ErbB2)
positive breast
cancer in
PNH patients are
also at increased
risk of forming lifethreatening blood
clots, or
thromboses,
Safety: Soliris increases susceptibility to N. Meningitides. Labeling contains a which are a
boxed warning requiring meningococcal vaccination prior to therapy. All
leading cause of
patients who discontinue eculizumab should be monitored for signs/symptoms death
of intravascular hemolysis, including evaluation of lactate dehydrogenase.
(approximately
The most common adverse reactions (≥10%) were headache,
50%) in this
nasopharyngitis, back pain, and nausea.
disease. No drugs
are currently
Dosing: 600 mg IV every 7 days for the first 4 weeks, followed by 900 mg for approved to treat
the fifth dose 7 days later, then 900 mg every 14 days thereafter.
PNH. Estimates
suggest that up to
How Supplied: As 300 mg vials containing 30 mL of 10 mg/mL solution per
2,000 - 10,000
vial. Vials must be stored under refrigerated conditions at 2-8º C (36-46º F)
people in the U.S.
and protected from light.
suffer from this
condition.
Lapatinib, a dual tyrosine kinase inhibitor, is a potent, reversible inhibitor of
A National Cancer Est $2900
ErbB1 and ErbB2. Overexpression of these receptors has been reported in a Institute (NCI)
per month
variety of tumors and is associated with poor prognosis and reduced survival, report estimates
and stimulation of these receptors is associated with cell proliferation and in
that about 1 in 8
tumor progression, invasion, and metastasis. Tykerb will be compared to
women in the US
Herceptin®. Tykerb is a small molecule that blocks the function of HER2 and (~13%) will
other proteins; Herceptin®, a monoclonal antibody, is a large protein that
develop breast
targets the part of the HER2 protein on the outside of the cell.
cancer during her
lifetime. The
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33 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
3/13/07
Tekturna®
Indication
women who
have received
prior therapy,
including
Herceptin
As
monotherapy
(aliskiren)
and
combination
Novartis/Speede treatment of
l
high blood
pressure.
Therapeutic Considerations
Affected
Population
Costs
(AWP)
Efficacy:
Efficacy was proven in a randomized trial in about 400 women with HER2
positive advanced or metastatic breast cancer. Patients were treated with
lapatinib plus capecitabine or capecitabine alone. Compared to patients
receiving capecitabine alone, the group of patients receiving lapatinib plus
capecitabine had a significant improvement in the time to tumor progression.
In addition, the tumor response rate was higher in the group of patients
receiving lapatinib plus capecitabine (24% vs. 14%). The survival data are not
yet mature.
American Cancer
Society estimates
that each year
nearly 175,000
US women will be
diagnosed with
breast cancer.
43,300 women will
die from breast
cancer in 2005.
Safety:
About 4% of
The most commonly reported adverse events were diarrhea, nausea,
breast cancer
vomiting, rash and hand-foot syndrome (numbness, tingling, redness, swelling patients develop
and discomfort of hands and feet). Generally reversible decreases in heart
metastatic
function (that can lead to shortness of breath) were reported in a small
disease and the
percentage of patients.
average survival
time for patients
Dosing: An undivided dose of 1,250 mg once daily for 21 days and in
after diagnosis of
combination with capecitabine on days 1-14 of a 21 day cycle.
metastatic
disease is 18 to
How Supplied: Available in 250mg tablets requiring room temperature storage. 30 months.
Aliskiren is the first synthetic renin inhibitor. Tekturna will competewith other
anti-hypertensives that affect the renin system such as ACE Inhibitors (i.e.
lisinopril, others) and ARB agents (i.e. Diovan®, others).
Hypertension, or ~$3-5 per
high blood
day
pressure, affects
an estimated 25%
Efficacy:
of Americans and
Aliskiren was compared to placebo in 6 randomized, double-blind, 8-week
causes increased
trials in ~3,961 patients with mild-to-moderate hypertension. Aliskiren lowered risk of stroke,
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34 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Oral
Approved:
3/5/07
Indication
Therapeutic Considerations
blood pressure (BP) in all demographic subgroups, although Black patients
tended to have smaller reductions vs. Caucasians or Asians. In these trials,
aliskiren 150mg and 300mg resulted in a significant reduction in trough BP vs.
placebo. The range of systolic BP reduction greater than placebo with 150mg
was 2.1 to 9.3 mmHg and with 300mg was 5.1 to 11.2 mmHg. The reduction in
diastolic BP greater than placebo was 1.7 to 5.4 mmHg and 3.3 to 7.5 mmHg
respectively.
Affected
Population
Costs
(AWP)
heart attack,
kidney failure,
heart failure and
death.
Efficacy was demonstrated in combination therapy. Aliskiren and HCTZ were
studied alone and in combination in an 8-week, 2,776-patient trial. The
combination resulted in a greater reduction in BP vs. monotherapy. Aliskiren
and valsartan were studied alone and in combination in an 8-week, 1,797patient study. BP reductions with the combinations were greater vs.
monotherapies. In another trial, aliskiren 150 mg provided additional efficacy
when coadministered with amlodipine 5 mg, but the combination was not
significantly better than amlodipine 10 mg.
Safety:
The common adverse event was diarrhea (2.3%). Other GI symptoms
included abdominal pain, dyspepsia, and gastroesophageal reflux. Other
events include cough (1.1%) and rash (1%). Angioedema (0.06%) and edema
(0.4%) have been reported. Caution is advised in patients with severe renal
impairment. Pregnancy Categories C (1st trimester) and D (2nd and 3rd
trimesters). Aliskiren is metabolized by CYP3A4; drug interactions to consider
are listed in the product labeling.
Dosing: The recommended starting dose is 150 mg once daily. The daily dose
may be increased to 300mg if blood pressure is not adequately controlled.
High fat meals decrease absorption substantially.
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35 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
How supplied: 150mg and 300mg tablets supplied in bottles of 30 and 90
tablets and blister packs of 100 tablets.
Vyvanse™
Attention Deficit
Hyperactivity
(lisdexamfetami Disorder
ne)
(ADHD) in
pediatric
Oral
patients aged 6
to 12 years old
New River
Pharmaceutical/
Shire
Approved:
02/23/2007
Lisdexamfetamine is an amphetamine prodrug classified as a Schedule II.
Competitive products include Adderall XR® and Concerta®.
ADHD is one of
~$3-5 per
the most common day
psychiatric
Efficacy:
disorders of
Lisdexamfetamine demonstrated improvement in ADHD Rating Scale (ADHD- childhood and is
RS) scores vs. placebo (P<0.0001) after 4 weeks of once-daily treatment in
estimated to affect
230 children. Average reductions vs. baseline were 51% (21.8 points), 54%
five to seven
(23.4 points) and 59% (26.7 points) for 30 mg, 50 mg, and 70 mg,
percent of children
respectively. Each dose demonstrated efficacy in the morning (10:00 am);
and approximately
afternoon (2:00 pm); and evening (6:00 pm), vs. placebo. Lisdexamfetamine, four percent of the
Adderall XR® and placebo were compared in a study in children aged 6-12
adult population.
(N=52) with ADHD. Patients were randomly assigned to Adderall XR® (10, 20,
or 30 mg), Vyvanse (30, 50, and 70 mg), or placebo once daily. A significant
difference in behavior, (average ratings on Swanson, Kotkin, Agler, M.Flynn
and Pelham (SKAMP)-Deportment scores) was observed between
lisdexamphetamine vs. placebo.
Safety: Most adverse events were mild to moderate and occurred in the first
week. The most common adverse events were decreased appetite, insomnia,
headache and upper abdominal pain. Lisdexamfetamine carries a black box
warning regarding abuse potential. Pregnancy category: C.
Dosing: Lisdexamfetamine should be administered at the lowest effective
dosage once daily in the morning with or without food.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected
Population
Costs
(AWP)
How Supplied: 30mg, 50mg, 70mg capsules in bottles of 100 requiring room
temperature storage.
Lialda™
For the
induction of
(mesalamine)
remission in
patients with
Shire
active, mild to
Pharmaceuticals moderate
ulcerative
Extended
colitis (UC).
release oral
tablets
Approved:
1/16/07
The first once-daily mesalamine. Mesalamines are a well-established drug of
choice and often a first-line treatment for patients with mild to moderate UC.
Lialda utilizes MMX technology which delays the release of the drug to the
colon.
Once-daily Lialda contains the highest mesalamine dose per tablet (1.2 g), for
a dose of as few as two tablets. Other products require 3 to 4 doses per day
and 6 to 16 pills a day.
Efficacy:
The approval of Lialda was based on the results of two studies. The first study
assessed the efficacy of 2.4 g/day given in divided doses twice daily and 4.8
g/day given once daily vs. placebo in 262 patients. At eight weeks, both doses
were superior vs. placebo in the induction of remission (34.1% with 2.4 g/day,
29.2% with 4.8 g/day, and 12.9% with placebo). The second study assessed
the efficacy of Lialda 2.4g/day and 4.8g/day (once daily) vs. placebo in 255
patients. At eight weeks, both once daily doses were superior vs. placebo in
the induction of remission (40.5% with 2.4 g/day, 41.2% with 4.8 g/day, and
22.1% with placebo).
Safety:
The safety of Lialda beyond eight weeks has not been established. The most
common adverse events with 2.4 g/day and 4.8 g/day respectively were
headache (5.6% and 3.4%) and flatulence (4% and 2.8%). Lialda is
contraindicated in patients with hypersensitivity to salicylates. Caution in
patients with impaired hepatic or renal function.
New Drugs - 2007
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Ulcerative colitis $4.56 per
(UC) is a type of tablet
inflammatory
bowel disease
that produces
inflammation and
sores or ulcers
along the inside of
the large intestine,
also called the
bowel or colon.
This serious,
chronic
autoimmune
disease affects
approximately
500,000
Americans. A
recent study
conducted by the
Crohn's and
Colitis Foundation
of America
(CCFA) found that
65% of patients
with UC are poorly
37 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Dosing: Two to four 1.2g tablets to be taken once daily with meal for a total
daily dose of 2.4g or 4.8g. Treatment duration in controlled clinical trials was
up to 8 weeks.
Affected
Population
Costs
(AWP)
compliant with
their medication.
How Supplied: Red-brown film-coated tablets containing 1.2g mesalamine, in
bottles containing 120 tablets requiring room temperature storage.
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New Drug Approvals – 2007
Selected New Indications:
Drug
Manufacturer
Route
Approval date
thyrotropin alfa
(Thyrogen®)
Genzyme
Injection
New indication
approved: 12/17/07
Indication
In combination
with radioiodine
to ablate, or
destroy, the
remaining
thyroid tissue in
patients who
have had their
cancerous
thyroids
removed
Therapeutic Considerations
Affected Population
Costs
(AWP)
Thyrotropin was initially approved in the U.S. in 1998 for use as a diagnostic The American
$994 per
tool used to test for the recurrence of well-differentiated thyroid cancer.
Cancer Society
vial
estimates that in
Efficacy:
2007, about 33,550
Efficacy was demonstrated in a randomized trial comparing the rates of
new cases of thyroid
thyroid remnant ablation with hypothyroidism or thyrotropin therapy. Patients cancer will be
(n = 63) with thyroid cancer underwent thyroidectomy, then were treated with diagnosed in the
thyroid withdrawl (serum TSH > 25 μU/mL) or thyroxine replacement (serum United States.
TSH < 5 μU/mL). Patients in the thyroxine group then received thyrotropin
Approximately 90
0.9 mg IM daily on two consecutive days, and then radioiodine 24 hours after percent of all thyroid
the second dose. All patients received 100 mCi 131I ± 10%. The primary
cancers are wellendpoint, success of ablation, was assessed 8 mos later by a thyrotropindifferentiated,
stimulated radioiodine scan. The therapies were equally successful. One
making those
hundred percent of patients in both the thyroid withdrawal group and the
patients candidates
thyroxine plus thyrotropin group achieved thyroid bed activity <0.1%. No
for the remnant
visible thyroid bed activity was reported in 86% of the withdrawal group and ablation procedure.
75% of the thyrotropin group.
A follow-up study was conducted to confirm the status of thyroid remnant
after a median follow-up of 3.7 years following radioiodine ablation. Fifty-one
patients were enrolled; 48 received thyrotropin for remnant neck/whole body
imaging and/or Tg testing. Patients were still considered to be successfully
ablated if there was no visible thyroid bed uptake on the scan, or if visible,
uptake was less than 0.1%. The two treatment groups remained equally
successful with 100% of patients reporting no visible uptake in the thyroid
bed.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Overall, 48/51 patients (94%) had no evidence of cancer recurrence during
the 3.7 years of follow-up. Thyrotropin was noninferior to thyroid hormone
withholding for post-surgical ablation of remnant thyroid tissue.
Safety:
Adverse events reported during the trial for patients in the thyroid withdrawal
group vs. the thyrotropin group were: nausea 11.9% vs 3.1%), headache
(7.3% vs. 1.2%), fatigue (3.3% vs. 1%), hypercholesterolemia () vs. 3.1%),
and vomiting (2.9% vs. 0.7%). Pregnancy Category C.
Dosing:
A two-injection regimen is recommended: 0.9 mg intramuscularly (IM),
followed by a second 0.9 mg IM injection 24 hours later.
How Supplied:
Available as either in a two-vial kit or a four-vial kit. The two-vial kit contains
two 1.1 mg vials of thyrotropin alfa for injection. The four-vial kit contains two
1.1 mg vials as well as two 10 mL vials of Sterile Water for Injection.
Requires refrigerated storage.
valsartan
(Diovan®)
Novartis
Oral
(Priority review)
For the
treatment of
high blood
pressure in
children and
adolescents
ages six to 16
Valsartan is the second ARB approved (losartin was the first) for the
treatment of high blood pressure in children and adolescents.
High blood pressure $2.20 –
$2.60 per
has become a
dose
multigenerational
Efficacy:
health issue. Thirty
Approval of valsartan in children was based on a clinical study involving 261 percent of American
hypertensive pediatric patients 6 to 16 years of age, patients who weighed < adults are currently
35 kg received 10, 40 or 80 mg of valsartan daily (low, medium and high
living with high blood
doses), and patients who weighed ≥ 35 kg received 20, 80, and 160 mg of
pressure and now
valsartan daily (low, medium and high doses). At the end of 2 weeks,
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
New indication
approved: 12/3/07
Indication
Therapeutic Considerations
Affected Population
valsartan reduced both systolic (SBP) and diastolic blood pressure (DBP) in
a dose-dependent manner. Overall, the three dose levels of valsartan (low,
medium and high) significantly reduced SBP by -8, -10, and -12 mm Hg from
the baseline (BL), respectively. Patients were re-randomized to either
continue receiving the same dose of valsartan or were switched to placebo
(PBO). In patients who continued to receive the medium and high doses of
valsartan, SBP at trough was -4 and -7 mm Hg lower than patients who
received PBO. In patients receiving the low dose of valsartan, trough SBP
was similar to that of patients who received PBO.
there are reports that
nearly five percent of
children and
adolescents may
have this condition.
Experts suggest that
the increase in
incidence of high
blood pressure
among children and
Safety:
adolescents is linked
No relevant differences were identified between the adverse experience
to the growing
profile for pediatric patients aged 6-6 and that previously reported for adult
patients. In the treatment of hypertension, the most common adverse events pediatric obesity
are: headache, dizziness, viral infection, fatigue and abdominal pain. These epidemic.
adverse events occurred at the equal rate in patients treated with valsartan
and PBO. Pregnancy Category: D.
Dosing:
Starting dose: 1.3 mg/kg once daily (up to 40 mg total).
Dosing range: 1.3-2.7 mg/kg once daily (up to 40-160 mg total).
How Supplied:
Available as tablets in the following strengths: 40 mg, 80 mg, 160 mg, or 320
mg. All strengths are packaged in bottles of 90 tablets requiring room
temperature storage.
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Costs
(AWP)
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
duloxetine
(Cymbalta®)
Lilly
Oral
New indication
approved: 11/30/07
Indication
For the
maintenance
treatment of
major
depressive
disorder (MDD)
in adults
Therapeutic Considerations
Cymbalta was first approved in August 2004 for the treatment of major
depression. It is a selective serotonin and norepinephrine reuptake inhibitor
(SNRI), similar to venlafaxine (Effexor®/Effexor SR®).
Efficacy:
The efficacy of duloxetine for maintenance treatment of major depression
was established in a double-blind, placebo-controlled clinical trial. Patients
with major depression in the trial (n=533) received duloxetine 60 mg once
daily. After 12 weeks, 278 patients met the criteria for entering the
continuation phase and were randomly assigned to either duloxetine at the
same dose or to placebo (PBO) for 6 months. Patients on duloxetine
experienced a statistically longer time to relapse of depression than did
patients on PBO. Relapse was defined as an increase of two or more points
on the Clinical Global Impression - Severity scale (CGI-S) compared with that
obtained at week 12, and also meeting the criteria for major depressive
disorder for two consecutive visits.
Affected Population
Approximately 19
$3.95 million adults in the $4.50 per
U.S., or close to 10% dose
of the American
population, suffer
from major
depressive disorder.
Safety:
Common Side effects: nausea (20%), dry mouth (15%), constipation (11%),
insomnia (11%), dizziness (9%), fatigue (8%), somnolence (7%) and
decreased appetite (8%). In the maintenance phase pivotal trial, nausea was
the most frequently reported adverse event during the acute phase and was
reported as a reason for discontinuation for 2.1%. In the continuation phase,
there were no significant differences in reported adverse events between
patients taking duloxetine vs. PBO. Among patients who completed the first
12 weeks of the trial and entered the continuation phase, 3.6% reported
adverse events as reasons for discontinuation over the next 26 weeks
(continuation phase) of the study.
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Costs
(AWP)
42 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Dosing: Maintenance treatment: 60 mg/day.
How Supplied:
20mg delayed-release capsules in bottles of 60 and 30mg and 60mg
delayed-release capsules in bottles of 30, 90 and 1000. Requires room
temperature storage.
Aripiprazole
For use as an
adjunctive
(Abilify®)
treatment to
antidepressant
Bristol Myers Squibb s for Major
Depressive
Oral
Disorder
New indication
approved: 11/20/07
Aripiprazole is a dopamine partial agonist and was initially approved in 2002
for schizophrenia.
$14 - $20
Major depressive
per dose
disorder (MDD)
affects almost 13 to
Efficacy:
14 million adults,
The approval was based on results from 2 six-week, double-blind,
(6.7%) of the adult
randomized, placebo-controlled, multicenter studies (n=743). Enrolled
population and is
patients continued their present antidepressant (ADT) plus double-blind
one of the most
adjunctive PBO or adjunctive aripiprazole. All study participants received
common mental
one of the commonly prescribed ADTs, including: escitalopram, fluoxetine,
health disorders. It
paroxetine, sertraline or venlafaxine. The dosage range for adjunctive
is one of the leading
aripiprazole was 2-20 mg/day. The primary endpoint was mean change from causes of disability in
baseline (BL) in a measure called Montgomery-Asberg Depression Rating
the U.S. In 2000, the
Scale (MADRS), a 10-item clinician-rated scale used to assess symptoms.
total economic
The key secondary endpoint was the Sheehan Disability Scale (SDS), a 3burden of treating
item self-rated scale used to assess the impact of depression on
depression in the
work/school, social life and family life. For the primary endpoint, both studies U.S. was $83.1
showed that aripiprazole plus an ADT provided superior reduction of the
billion. A recent
MADRS Total Scores vs. ADT alone at 6 weeks. Aripiprazole plus an ADT
study evaluated
was also superior in reducing the mean SDS Total Score in one study
different treatment
approaches,
including adjunctive
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Safety:
Aripiprazole carries a black box warning regarding increased mortality in
elderly patients with dementia-related psychosis and a warning regarding
suicidality in children, adolescents and young adults. In a pooled analysis,
the rate of discontinuation due to adverse events with the use of adjunctive
Aripiprazole vs PBO plus ADT was 6 % vs 2 %, respectively. The most
commonly observed adverse events (>5%) associated with the use of
adjunctive Aripiprazole were akathisia (25 % vs 4 %), restlessness (12 % vs
2 %), insomnia (8 % vs 2 %), constipation (5 % vs 2 %), fatigue (8 % vs 4 %)
and blurred vision (6 % vs 1 %). In these studies, adjunctive Aripiprazole
demonstrated no important differences prolactin, fasting glucose, HDL, LDL
and total cholesterol. The median % change from BL in triglycerides was 5%
for Aripiprazole vs 0 % for PBO-treated patients. Weight gain ≥ 7% increase
from BL was seen in 5% of Aripiprazole-treated patients vs. 1% of PBOtreated patients. The mean change from BL in weight was 1.7 kilograms (kg)
for aripiprazole vs. 0.4 kg for PBO. Pregnancy Category C.
medications in
patients with MDD.
The study found that
63% of patients did
not achieve
adequate relief of
depressive
symptoms following
the initial treatment
with an
antidepressant
alone.
Dosing:
The starting dose is 2 mg/day to 5 mg/day; max dose of 15 mg/day. Dose
adjustments of up to 5 mg/day should occur gradually. No dosage
adjustments recommended as a result of possible drug interactions.
How Supplied:
Available as a tablet in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
strengths in bottles of 30 and 100 tablets; as ODT tablets in 15mg and 30mg
strengths in blister packs of 30 tablets, as a 1mg/ml oral solution in a 150 ml
size and as 7.5mg/mL intramuscular injection, requiring room temperature
storage.
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Costs
(AWP)
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
sorafenib
(Nexavar®)
Bayer HealthCare
AG
Oral
New indication
approved: 11/18/07
Indication
For the
treatment of
hepatocellular
carcinoma,
when the
cancer is
inoperable.
Therapeutic Considerations
Affected Population
Sorafenib is an anticancer drug called a kinase inhibitor. It interferes with
molecules involved in chemical messages sent within cancer cells, in the
formation of blood vessels that supply tumors, and in cell death.
Costs
(AWP)
$49.28
Hepatocellular
carcinoma accounts each tablet
for 80-90% of all liver
cancers. If all of the
Efficacy:
cancer cannot be
Efficacy was based on the results of an international randomized placeboremoved by surgery,
controlled trial in patients (n=602) with inoperable hepatocellular carcinoma. it is usually fatal
Both groups were comparable with regard to age, gender, race, the stage
within 3-6 mos. The
and other characteristics of cancer, and the prior types of cancer treatment
American Cancer
received. The trial was stopped after a planned interim analysis showed a
Society estimates
significant advantage in overall survival for the patients receiving Sorafenib. 19,160 new cases
Patients who received Sorafenib survived a median of 10.7 mos vs a median and 16,780 deaths
of 7.9 mos for patients randomized to PBO. A separate analysis showed that from cancer of the
tumors progressed more slowly in patients who received Sorafenib vs. those liver and intrahepatic
receiving PBO.
bile duct in the US in
2007.
Safety:
The most common adverse events observed in patients taking Sorafenib
(>20%) are fatigue, weight loss, rash or superficial skin shedding, hand or
foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain.
Sorafenib and PBO therapy in patients with hepatocellular carcinoma
resulted in diarrhea (55% of patients who received Sorafenib. Cardiac
ischemia occurred in patients treated with Sorafenib and PBO (2.7% and
1.3% respectively) and new high blood pressure was reported in 9% and 4%
respectively. Elevated serum lipase occurred in 40% who received
Sorafenib, vs 37% who received PBO, and hypophosphatemia, occurred in
35% vs. 11% respectively.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Dosing: The usual dose is two tablets (400 mg) taken twice a day on an
empty stomach.
How Supplied:
Available as 200 mg tablets in bottles of 120 tablets requiring room
temperature storage.
Rosuvastatin
(Crestor®)
Astra Seneca
Oral
New indication
approved:11/8/07
As adjunctive
therapy to diet
to slow the
progression of
atherosclerosis
in adult
patients as part
of a treatment
strategy to
lower Total-C
and LDL-C to
target levels.
Rosuvastatin was initially approved in 2003.
Efficacy:
Efficacy was proven in the Measuring Effects on Intima Media Thickness: an
Evaluation Of Rosuvastatin 40 mg(METEOR) study. The effect of
rosuvastatin carotid atherosclerosis was assessed by B-mode
ultrasonography in patients with elevated LDL-C, at low risk for symptomatic
coronary artery disease and with subclinical atherosclerosis as evidenced by
carotid intimal-medial thickness (cIMT). In this double-blind, placebocontrolled clinical study 984 patients were randomized in a 5:2 ratio to
rosuvastatin 40 mg or placebo (PBO) once daily. Ultrasonograms of the
carotid walls were used to determine the annualized rate of change per
patient from baseline to two years in mean maximum cIMT of 12 measured
segments. The estimated difference in the rate of analyzed over all 12 carotid
artery sites between rosuvastatin-treated patients and PBO-treated patients
was -0.0145 mm/year (95% CI –0.0196, –0.0093; p<0.0001). The
annualized rate of change from baseline for the PBO group was +0.0131
mm/year (p<0.0001). The annualized rate of change from baseline for the
rosuvastatin group was - 0.0014 mm/year (p=0.32).
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Atherosclerosis is
$3.58 per
the progressive
tablet all
buildup of plaque in doses
the inner walls of
arteries. The
condition is a
consequence of
elevated cholesterol,
with no visible signs
or symptoms. The
disease can begin in
early adulthood and
continues to
progress for the rest
of a person’s life.
46 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Safety:
Most frequent adverse reactions (≥ 2%) are headache, myalgia, abdominal
pain, asthenia, and nausea. Drug interactions may occur with concomitant
use of cyclosporine, gemfibrozil, lopinavir/ritonavir, coumarin anti-coagulants,
and fibrates or niacin products. Pregnancy category: X.
Dosing: 5mg – 40mg daily.
How Supplied:
5mg, 10mg, 20mg and 40mg tablets in bottles of 30, 90 and 100 tablets
requiring room temperature storage.
Menactra®
(Meningo-coccal
poly-saccharide
diphtheria toxoid
conjugate vaccine)
Sanofi Pasteur
Injection
New indication
approved: 10/19/07
Expanded age
group:
meningitis
vaccine for
ages 2-10.
Menactra was originally approved in January 2005 for protection against
meningococcal disease in adolescents and adults aged 11-55 years.
In October 2007, the FDA granted licensure to expand the indication for the
meningococcal conjugate vaccine to include children 2 years through 10
years of age.
Meningococcal
$223.20
disease is a rare but per dose
serious bacterial
infection that strikes
between 1,400 and
2,800 Americans
Efficacy: The efficacy of Meningo-coccal poly-saccharide diphtheria toxoid
every year, causing
conjugate vaccine is well established.
meningitis or sepsis.
Approximately 10%
Safety: Guillain-Barré syndrome (GBS) has been reported in temporal
who contract the
relationship following use. Persons previously diagnosed with GBS should
disease will die. Of
not receive Menactra vaccine. The stopper of the vial contains dry natural
those who survive,
rubber latex, which may cause allergic reactions in latex-sensitive individuals. up to 20% suffer
There is no latex in any component of the syringe. Because IM injection can permanent
cause site hematoma, the vaccine should not be given to persons with any
disabilities.
bleeding disorder or to persons on anticoagulant therapy unless the potential Meningococcal
benefits clearly outweigh the risk. Pregnancy Category: C.
disease often begins
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Dosing: A single 0.5 mL injection by the intramuscular route.
Affected Population
Costs
(AWP)
with flu-type
symptoms.
How Supplied: 0.5mL syringe or vial requiring refrigerated storage.
Januvia™
(sitagliptin)
Merck
Oral
New indication
approved: 10/12/07
As initial
therapy in
combination
with metformin;
an add-on
therapy in
combination
with
sulfonylureas
or with both
sulfonylureas
and metformin
for treatment of
type 2
diabetes.
The new regimens with sitagliptin described in the updated labeling include:
 as an adjunct to diet and exercise, initial therapy in combination with
metformin;
 add-on therapy to a sulfonylurea (glimepiride) when the single agent
alone does not provide adequate glycemic control; and,
 add-on therapy to the combination of a sulfonylurea (glimepiride) and
metformin when dual therapy does not provide adequate glycemic
control.
Nearly 21 million
All doses:
people in the U.S.
$6.07 per
(7% of the
tablet
population), have
diabetes, with type 2
diabetes accounting
for >90% of the
cases.
Approximately 66%
of people diagnosed
Efficacy:
The efficacy of sitagliptin as initial therapy in combination with metformin was with type 2 diabetes
have inadequate
evaluated in a double-blind, placebo-controlled trial in patients with type 2
control of blood
diabetes and inadequate glycemic control on diet and exercise. Patients
were randomized to placebo (n=165), 100mg siltagliptin once daily (n=175), sugar (A1C < 7% as
recommended by the
500mg (n=178) or 1000mg (n=177) metformin BID, or 5 mg sitagliptin BID
American Diabetes
plus 500mg or 1000mg metformin BID(n=178). At 24 weeks, mean
Association). It is
reductions from baseline in A1C were: sitagliptin 100mg -0.7%; metformin
500mg, -0.8%; metformin 1000mg, -1.1%; sitagliptin 50mg/metformin 500mg estimated that one in
three Americans
bid, -1.4%; sitagliptin 50mg/metformin 1000mg bid, -1.9%; and placebo, born in 2000 will
0.2%.
develop diabetes in
their lifetime. There
The efficacy of sitagliptin in combination with glimepiride, with or without
metformin was evaluated in a double-blind, placebo-controlled study patients are currently more
than 194 million
with type 2 diabetes treated with glimepiride (≥4mg daily) alone or with
people with diabetes
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
metformin (≥1,500mg daily. Patients were randomized to the addition of
either 100mg sitagliptin or placebo, administered once daily. In combination
with glimepiride, with or without metformin, sitagliptin therapy vs. placebo
resulted in a mean reduction from baseline A1C of -0.7% and in FPG of -20
mg/dL.
Affected Population
Costs
(AWP)
worldwide.
Safety:
Adverse events reported in ≥5% and more commonly than placebo are:
upper respiratory tract infection, nasopharyngitis and headache.
Hypoglycemia was also reported more commonly in patients treated with the
combination of sitagliptin and sulfonylurea, with or without metformin, than in
patients given the combination of placebo and sulfonylurea, with or without
metformin. Post-marketing reports contributed to updated labeling in the
Warnings and Precautions section of the label on hypersensitivity reactions.
These reactions include anaphylaxis, angioedema and exfoliative skin
conditions including Stevens-Johnson syndrome. Pregnancy Category: B.
Dosing: The recommended dose of sitagliptin is 100 mg once daily with or
without food.
How Supplied: 100 mg, 50 mg, and 25 mg tablets in 30, 90 or 100 tablets
requiring room temperature storage.
Erbitux®
(cetuximab)
ImClone/BMS
For improved
overall survival
in the third-line
treatment of
patients with
metastatic
Cetuximab is an IgG1 monoclonal antibody (IgG1 MAb) designed to inhibit
the function of the epidermal growth factor receptor (EGFR, HER1, c-ErbB1). EGFR is part of a signaling pathway that is linked to the growth,
development, and survival of many human cancer cells.
This new indication is an update to the product labeling to include overall
New Drugs - 2007
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In the U.S.,
approximately
149,000 people will
be diagnosed with
cancer of the colon
or rectum this year.
$600 per
100mg
vial;
$1,200 per
200mg vial
49 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
IV infusion
New indication
approved: 10/2/07
Indication
colorectal
cancer
Therapeutic Considerations
Affected Population
survival data as a single agent in epidermal growth factor inhibitor (EGFR)Half of these patients
expressing metastatic colorectal cancer (mCRC) patients after failure of both have metastatic
irinotecan- and oxaliplatin-based regimens.
disease, or cancer
that has spread to
Efficacy:
other organs, at the
In one trial, 572 patients who had failed two rounds of chemotherapy were
time of diagnosis.
randomized to best supportive care (BSC) alone or BSC plus cetuximab.
EGFR is expressed
Overall survival increased from a median of 4.6 months to 6.1 months with
in up to 77.7 % of
cetuximab. Among patients on cetuximab, 19 (6.6%) had complete or partial colorectal cancer
responses; none of those on supportive care alone had such improvements. tumors. Colorectal
Cetuximab also was associated with a 32% decrease in the risk of
cancer is the third
progression, which was statistically significant.
most common
cancer in both men
In the EPIC trial, 1,298 patients who had failed one round of chemotherapy and women.
were randomized to irinotecan alone or irinotecan plus cetuximab. The
combination resulted in an increase in progression-free survival from 2.6
months to 4 months and an increase in the response rate from 4% to 16%,
with both differences being significant.
Safety:
Cetuximab carries a black box warning regarding serious infusion reactions,
some fatal, in approximately 3% of patients and cardiopulmonary arrest
and/or sudden death in 2% of patients when administered in combination
with radiation therapy. The most common adverse events are diarrhea,
fatigue, and an acneiform rash, and severe infusion reactions are also
possible. The rash appears to correlate with treatment effectiveness. Patients
who did not experience a skin reaction had a response rate of 4%-5%, while
those with severe skin reactions had a 55% response rate. Pregnancy
Category: C.
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Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Dosing:
Premedicate with an H1 antagonist. 400 mg/m2 initial dose as a 120-minute
IV infusion, followed by 250 mg/m2 weekly, infused over 60 minutes.
How Supplied:
100 mg/50 mL, single-use vial; and 200 mg/100 mL, single-use vial requiring
refrigerated storage.
Taxotere®
(Docetaxel)
Sanofi-Aventis
Injection
Approved: 9/28/07
For use in
combination
with cisplatin
and 5fluorouracil for
induction
therapy of
locally
advanced
squamous cell
carcinoma of
the head and
neck (SCCHN)
before patients
undergo
chemoradiother
apy and
surgery.
Docetaxel in combination with cisplatin and fluorouracil (5-FU) was approved More than 640,000
in 2006 for the induction therapy of inoperable advanced SCCHN. This is the people worldwide are
eighth FDA approved indication for docetaxel in five different tumor types.
diagnosed with head
and neck cancer
Efficacy:
each year, and more
The efficacy was based on the “TAX 324” trial performed in patients with
than 350,000 die
tumors of the oropharynx, larynx, hypopharynx or oral cavity that either could from the disease
not be removed, were considered potentially operable but unlikely to be
annually. Head and
cured with surgery, or could not be removed in order to preserve organ
neck cancer is a
function.
group of many
related diseases that
Patients were treated every 3 weeks for 3 cycles with either TPF (n=251;
mostly begin in the
docetaxel (Taxotere) 75 mg/m2 plus cisplatin 100 mg/m2 and 5-FU 1000
mg/m2 / day x 4 days) or PF (n=243; cisplatin 100 mg/m2 followed by 5-FU cells that line the
mucosal surfaces in
1000 mg/m2 /day x 5 days), the standard therapy. Both groups of patients
the head and neck
were then given weekly chemotherapy (carboplatin) together with radiation
area such as the
for 7 weeks, followed by surgery for select patients. The primary endpoint
mouth, nose and
was survival. Secondary endpoints included progression-free survival,
throat. The term
response rates, toxicity and quality of life.
encompasses
The relative risk of death was 30% lower in the group assigned to TPF vs. PF cancers of the oral
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$852.78
per mL
$1,705.53
per
80mg/2
mL vial.
51 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
(HR 0.70; p=0.0058) with a median overall survival of 70.6 mos vs. 30.1 mos cavity, salivary
respectively. The probability to survive three years was 62% in the TPF arm glands, paranasal
compared to 48% in the PF arm.
sinuses and nasal
cavity, pharynx,
Safety:
larynx, and lymph
Docetaxel carries a boxed warning regarding the following risks:
nodes in the upper
part of the neck.
 Increased treatment-related mortality in patients with abnormal liver
function, use of high doses or select non-small cell lung cancer patients;
 increased toxicity in patients with liver dysfunction;
 increased toxicity in patients with neutropenia; hypersensitivity reactions;
 severe fluid retention.
In the TAX324 trial, the incidence of grade 3/4 toxicity was 65% in the TPF
vs. 62% in the PF group. Patients treated with TPF had more febrile
neutropenia (12% vs 7%), neutropenic infection (12% vs 8%), and grade 3/4
neutropenia (84% vs. 56%), dizziness (4% vs. 2%), alopecia (4% vs 1%) and
diarrhea (7% vs. 3%) than those in the PF group. Patients in the PF group
had more grade 3/4 thrombocytopenia (11% vs. 4%), stomatitis (27% vs.
21%), lethargy (10% vs. 5%) and vomiting (10% vs. 8%). The incidence of
other grade 3/4 events was similar between the two groups, such as nausea,
anorexia and constipation.
Dosing:
The dose varies with a range of 60 – 100mg/m2 infused IV over 1 hour. For
this indication the dose is 75mg/m2 daily for 4-5 days every 3 wks for 3-4
cycles. The dose is adjusted based on diagnosis, liver function, renal
function and tolerance or toxicities. Pre-medication with corticosteroids is
recommended.
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Drug
Manufacturer
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Approval date
Indication
Therapeutic Considerations
Affected Population
How Supplied:
Available as single-dose vials with diluent in the following strengths:
80mg/2mL and 20mg/0.5mL requiring storage between 2 and 25°C (36 and
77°F).
cold adapted
influenza vaccine,
trivalent (CAIV-T),
(Flumist®)
Medimmune
intranasal
New patient
population
approved: 9/19/07
for the
prevention of
influenza in
children 2 to 5
years of age
who do not
have a history
of wheezing or
asthma
Intranasal influenza vaccine (CAIV-T = cold adapted influenza vaccine,
trivalent) is a new refrigerator stable formulation of Flumist which was
previously a formulation that required frozen storage. CAIV-T has previously
been approved for use in patients 5 to 49 years of age.
Efficacy: The efficacy of intranasal influenza vaccine in children 2-5 years of
age was demonstrated in a multinational, double-blind trial. Children were
randomized to intranasal vaccine (n=3,916) or injectable vaccine (n=3,936).
Patients were followed through the flu season to identify viral illness. As the
primary endpoint, culture-confirmed modified CDC-ILI (CDC-defined
influenza-like illness) was defined as a positive culture for a wild-type
influenza virus associated within ±7 days of modified CDC-ILI. Modified
CDC-ILI was defined as fever (temp>100°F oral) plus cough, sore throat, or
runny nose/nasal congestion on the same or consecutive days. In the
analysis, there were 53 cases (1.4%) of CDC-ILI in the group assigned to
intranasal vaccine vs. 93 (2.4%) in the group assigned to injectable vaccine
representing a 44.5% (95%CI: 22.4, 60.6) reduction in influenza rate with
intranasal vaccine.
Safety: Adverse events reported in >2% of children in clinical trials (higest
percentage from any clinical trial listed in product labeling) were: wheezing
(5.9%), hospitalization due to any cause (4.2%), runny nose/nasal
congestion (58%), decreased appetite (21%), irritability (21%), lethargy
(14%), sore throat (11%), headache (9%), muscle aches (6%), fever (9%).
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The CDC
recommends that
healthy children
aged 6 mos up
through age 5 get a
flu vaccine. Children
< 2 years old are at
high risk of
hospitalization if they
get the flu. Each
year, over 20,000
children are
hospitalized as a
result of influenza.
This year, Nov. 27,
2007, is set aside as
Children’s Flu
Vaccination Day.
This day will help
raise awareness
about the value of
vaccinating
children—especially
high-risk children—
53 of 120
Costs
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Intranasal flu vaccine is contraindicated in patients with a hypersensitivity to
eggs, egg proteins, gentamicin, gelatin, arginine, a history of a life
threatening reaction to previous influenza vaccination, or concomitant aspirin
therapy in children/adolescents. Pregnancy Category: C.
Affected Population
Costs
(AWP)
and their close
contacts. Info at:
http://www.cdc.gov/
flu/protect/
children.htm
Dosing: For children age 2 - 8 years who have not previously received flu
vaccine, the dose is one 0.2 mL spray intranasally (0.1 mL per nostril)
followed by a second 0.2 mL dose given at least 1 month later. For all other
individuals, including children age 2-8 years who have previously received
influenza vaccine, the recommended schedule is one 0.2 mL dose.
How Supplied: Supplied in a package of 10 pre-filled, single-use sprayers
requiring refrigerated storage.
alemtuzumab
(Campath®)
Genzyme
Corporation
Intravenous
Approved: 9/19/07
For use as a
single agent for
treatment of Bcell chronic
lymphocytic
leukemia (BCLL)
Alemtuzumab was previously approved for treatment of B-cell chronic
lymphocytic leukemia (B-CLL) in patients who had been treated with
alkylating agents and who had failed fludarabine therapy.
B-CLL is the largest $2,007.10
subset of chronic
per 30mg
lymphocytic
vial
leukemia (CLL), the
Efficacy:
most common form
The efficacy as single agent therapy in B-CLL was demonstrated in 297
of adult leukemia. It
patients randomized to alemtuzumab (after dose escalation, 30mg IV 3
is characterized by
times/wk on alternate days for 12 wks) or chlorambucil (40 mg/m2 orally
accumulation of
every 28 days for up to 12 cycles). Patients had Rai stage I - IV, were
immature cells in the
previously untreated with chemotherapy, and had progressive disease.
bone marrow, blood,
Alemtuzumab resulted in an improvement in progression-free survival (PFS) lymph and other
vs. chlorambucil (median PFS: 14.6 vs. 11.7 months); HR= 0.58, (95%CI:
organs.
0.43; 0.77) p=0.0001. Patients receiving alemtuzumab also demonstrated an Approximately
increased complete response rate (24% vs. 2%; p><0.0001) vs.
15,000 new cases of
chlorambucil.
B-CLL are diagnosed
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Safety:
Alemtuzumab carries a black box warning regarding serious cytopenias,
infusion reactions and infections. Alemtuzumab induces severe and
prolonged lymphopenia and increases risk of infection. Live viral vaccine use
is discouraged in patients who have recently received alemtuzumab. Most
common adverse events (all grades and >10%): cytopenias (97%), infusion
reactions (69%), cytomegalovirus (CMV) (55%) and other infections (74%),
headache (14%), rash or urticaria (16%), dypsnea (14%), diarrhea (15%),
and insomnia (10%). Pregnancy category: C.
in the US each year.
Symptoms include
fatigue, bone pain,
night sweats, fevers,
and weight loss.
Patients are
susceptible to
bleedings and a
weak immune
system, exposing
them to risk of
infection.
Dosing:
Administered IV over 2 hours. Dosing is initiated at 3mg daily until infusion
reactions are < grade 2, then 10mg daily until reactions are < grade 2, then
30mg/day three times a week on alternate days. Total duration of therapy is
12 weeks (including from the day of initial dosing). Premedicate with oral
antihistamine and acetaminophen prior to dosing.
How Supplied:
Vials containing 30mg/mL solution. Each carton contains one or three vials
requiring storage at 2-8°C (36-46°F).
levofloxacin
(Levaquin® )
Ortho-McNeil
oral
For high-dose,
short-course
treatment of
complicated
urinary tract
infections
(cUTI) and
acute
Levofloxacin was initially approved in 1996. The new indication is for high
dose, short course treatment of a serious infection. Levofloxacin competes
with ciprofloxacin which is available as a generic. As discussed below, the
ciprofloxacin dose for cUTI and AP is 500mg twice daily for 10 days.
Acute pyelonephritis
is a potentially
organ- and/or lifethreatening infection
that causes scarring
Efficacy: The efficacy of levofloxacin 750mg daily in cUTI with AP was
of the kidney with
proven in a double-blind, multicenter trial. Patients (N=1109) were
each infection and
randomized to levofloxacin 750 mg IV or orally once daily for 5 days (n=546) may lead to
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Drug
Manufacturer
Route
Approval date
New indication
approved: 9/17/07
Indication
pyelonephritis
(AP).
Therapeutic Considerations
Affected Population
or ciprofloxacin 400 mg IV or 500 mg orally twice daily for 10 days (n=563).
Efficacy was measured by bacteriologic eradication of the organism(s) at the
post-therapy visit (10 to 14 days after the last dose of levofloxacin and 5 to 9
days after the last dose of ciprofloxacin). The bacteriologic cure rates overall
for levofloxacin x 5 days were equivalent to those after 10 days of
ciprofloxacin (75.7% vs. 75.2% in the intention to treat population,
respectively; and 86% vs. 89.2% in the microbiologically evaluable patients,
respectively).
significant damage to
the kidney, kidney
failure, sepsis, or
multiorgan failure.
The frequency in
preschool girls is 80
years, 18-43%; and
in men >80 years,
5.4-21%. More than
Safety: Serious adverse events can include: anaphylactic reactions, allergic 250,000 cases occur
skin reactions, peripheral neuropathy, liver, hematologic (including
in the US each year,
agranulocytosis, thrombocytopenia), and renal toxicities, achilles or other
and approximately
tendon rupture, central nervous system effects, including convulsions,
200,000 patients
anxiety, confusion, depression, and insomnia. Clostridium difficile-associated require
colitis has been reported. Prolongation of the QT interval and isolated cases hospitalization. Ref:
of torsade de pointes have been reported; it is recommended to avoid use in http://www.emedicin
patients with known prolongation, those with hypokalemia, and with drugs
e.com
that prolong the QT interval. The most common adverse events (≥3%) are
nausea, headache, diarrhea, insomnia, constipation and dizziness.
Pregnancy Category: C.
Dosing: The recommended dosage is 750mg orally once daily. The dose
should be reduced in patients with compromised renal function.
How Supplied: As 250 and 500mg tablets in bottles of 50 and unit dose
packs of 100 tablets. 750mg tablets are available in bottles of 20 and unit
dose packs of 5 (Leva-pak) and 100 tablets. Levofloxacin is also available as
an oral solution. Each bottle contains 480 mL (25 mg/mL). Required storage
is 25°C (77°F).
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Approval date
Raloxifene
(Evista®)
Lilly
oral
New indication
approved: 9/14/07
Indication
For the
reduction in
risk of invasive
breast cancer
in
postmenopaus
al women with
osteoporosis
and
postmenopaus
al women at
high risk for
breast cancer
Therapeutic Considerations
Evista is a selective estrogen receptor modulator (SERM) previously
indicated for the treatment and prevention of osteoporosis in
postmenopausal women.
Efficacy: Efficacy was established in 2 pivotal trials and 2 supportive trials:
* Study of Tamoxifen and Raloxifene (STAR) trial
* Raloxifene Use for The Heart (RUTH) trial
* Multiple Outcomes of Raloxifene Evaluation (MORE) and
* Continuing Outcomes Relevant to EVISTA (CORE) trial.
MORE: Primary objective was the study of the effect on osteoporosis in postmenopausal women. The effect on breast cancer reduction was found as a
secondary safety endpoint. After 4 years of treatment, patients randomized to
raloxifene 60mg daily (n=2557) experienced a reduced incidence of all breast
cancers by 62% (HR 0.38; 95%CI: 0.22;0.67) and ER+ invasive breast
cancer by 80% (HR 0.20; 95%CI: 0.08;0.49) vs. placebo (n=2576). No
difference was found in the risk of non-invasive cancer.
CORE: This trial was a 4 year extension of MORE. Up to 8 years after
randomization, raloxifene (n=1355) reduced the incidence of ER+ invasive
breast cancer by 65% vs. placebo (n=1286).
RUTH: This trial studied use of raloxifene in >10,000 women - all known to
have or be at high risk for heart disease - for seven years. Patients receiving
raloxifene (n=5044) experienced a reduction in risk of ER+ invasive breast
cancer by 55% (HR 0.45: 95%CI: 0.28; 0.72) compared to placebo.
Affected Population
The American
Cancer Society
estimates
approximately
180,000 women are
diagnosed with
invasive breast
cancer each year.
While the exact
causes of breast
cancer are unknown,
there are certain risk
factors linked to the
disease, including
age, family history,
personal history of
breast cancer,
genetics, race and
lifestyle factors.
Increased age is a
particularly important
risk factor, as nearly
eight out of 10 breast
cancers are found in
postmenopausal
women age 50 and
older.
STAR: In the STAR trial, raloxifene and tamoxifen each reduced the risk of
developing invasive breast cancer by roughly 50%. Of the 19,747
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Drug
Manufacturer
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Approval date
Indication
Therapeutic Considerations
Affected Population
postmenopausal women at increased risk for invasive breast cancer enrolled,
women assigned to take raloxifene had 36% fewer uterine cancers and 29%
fewer blood clots than women treated with tamoxifen.
Safety: Raloxifene therapy is associated with an increased risk of Venous
Thromboembolism and strokes and labeling carries a black box warning
regarding these events. Adverse events (>2% and more common than
placebo) include: hot flashes (9.7% - 24.6%), leg cramps (5.9% - 7%),
peripheral edema (3.3% - 5.2%), flu syndrome (13.5% - 14.6%), sweating
(2.5% - 3.1%). Pregnancy Category: X.
Dosing: The dose is one 60mg tablet by mouth daily.
How supplied: Supplied as 60mg tablets in bottles of 30, 100 and 2,000
requiring room temperature storage.
palonosetron
hydrochloride
(Aloxi®)
MGI PHARMA and
HELSINN
Injection
New labeling
approved: 9/4/07
For prevention
of acute and
delayed
nausea and
vomiting (N&V)
associated with
initial and
repeat courses
of moderately
and acute N&V
with highly
emetogenic
cancer
Palonosetron is a 5-HT3 antagonist anti-emetic agent. It is similar to
ondansetron (Zofran) and dolasetron (Anzemet). Unlike the other therapies
which are available for oral or IV use, palonosetron is only available for IV
use. Palonosetron is not currently indicated for post-operative nausea and
vomiting. The September 2007 labeling change for palonosetron involved the
removal of dosing restrictions. Previous to this recent label revision, the
doses had been restricted to one per seven days. See actual label wording
below:
Chemotherapyinduced emesis
(CIE) is one of the
most distressing
effects of cancer
treatment. Three
distinct types of CIE
are defined: acute
(within first 24
Previous Dosage (2006): The recommended dosage is 0.25 mg administered hours), delayed (>24
as a single dose approximately 30 minutes before the start of chemotherapy. hours after
Repeated dosing within a seven day interval is not recommended because
treatment), and
the safety and efficacy of frequent (consecutive or alternate day) dosing in
anticipatory. found
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Drug
Manufacturer
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Approval date
Indication
Therapeutic Considerations
chemotherapy. patients has not been evaluated.
Dosing new (2007): Dosage for Adults - a single 0.25 mg I.V. dose
administered over 30 seconds. Dosing should occur approximately 30
minutes before the start of chemotherapy.
Safety:
The most common adverse reactions (incidence ≥5%) are headache (9%)
and constipation (5%). Palonosetron should be administered with caution in
patients who have or may develop prolongation of QTc. The incidence of QT
prolongation in trials was <1%. Palonosetron is not an inhibitor nor inducer
of CYP enzymes; the potential for clinically significant drug interactions with
palonosetron appears to be low. Pregnancy Category: B.
How Supplied:
0.25 mg/5 mL (free base) single-use vial requiring room temperature storage.
Risperdal®
(Risperidone)
J&J
Oral
For the
treatment of
pediatric
patients ages
13-17 with
schizophrenia
and for the
short-term
Risperidone is the first drug to be approved for treating schizophrenia in
adolescents and the first atypical antipsychotic to receive approval for
treating bipolar disorder in pediatric patients. As a result of the pediatric
studies, J&J has six months of additional exclusivity for its three risperidone
patents, delaying introduction of generic versions of the drug beyond the first
patent's Dec. 29, 2007.
Although this is the initial atypical antipsychotic to receive the indication,
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Affected Population
Acute CIE is
reported to occur in
13 - >35% of
patients. Delayed
CIE in 60% and 50%
of patients treated
with highlyemetogenic
chemotherapy
(HEC), and in 52%
and 28% of patients
receiving
moderatelyemetogenic
chemotherapy
(MEC). Delayed
symptoms appeared
after HEC (emesis,
38%; nausea, 33%)
and MEC (emesis,
19%; nausea, 21%).
Schizophrenia
affects 1% of the
population. It is a
chronic disorder that
begins in early
adulthood and is
characterized by
delusional beliefs,
Costs
(AWP)
Per tablet:
0.25mg =
$4.05
0.5mg =
$4.45;
1mg =
$4.73;
2mg =
59 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
(Priority review)
New indication
approved: 8/22/07
Indication
treatment of
manic or mixed
episodes of
bipolar I
disorder in
children and
adolescents
ages 10 to 17.
Therapeutic Considerations
Affected Population
Zyprexa (olanzapine) and Abilify (aripiprazole) may receive approval soon for auditory
similar indications.
hallucinations, and
disorganized thought
Efficacy:
patterns.
In double-blind, placebo-controlled trials used to support the new risperidone Bipolar disorder,
indications - two for schizophrenia and one for bipolar I disorder - treated
sometimes called
patients exhibited fewer symptoms of their illness. All three trials looked at
manic-depressive
two doses and found that the higher dose did not appear to increase efficacy. illness, involves
In one of the trials, 160 patients were randomized to two dosage ranges of
episodes of
risperidone: 1 mg-3 mg/day and 4 mg-6 mg/day. Improvement in mean
depression
PANSS total scores at endpoint were statistically significant. At the 1 mg-3 alternating with
mg dose, PANSS was -21.3; at 4 mg-6 mg, it was -21.2. The mean score for episodes of mania. It
placebo was -8.9.
is believed to be
hereditary and to
Safety:
affect about 2% of
The safety profile in pediatric patients is similar to that found in adults.
the population.
Because of concern about the drug's effect on growth and development, J&J
is conducting a study to evaluate metabolic effects on weight and growth
hormone and prolactin over a longer period of time.
Costs
(AWP)
$7.90;
3mg =
$9.29
4mg =
$12.48
Dosing: At the time of this report preparation, FDA approved dosing
recommendations were not available.
How Supplied: As 0.25, 0.5, 1.0, 2.0, 3.0 and 4.0mg tabs in bottles of 60.
As 1mg/mL oral solution in a 30 mL bottle. As 0.5, 1.0, 2.0, 3.0 and 4.0 mg
orally disintegrating tabs in packs of 7, 28 or 30 tabs. The injection is
available in dosage strengths of 12.5, 25, 37.5, or 50mg. It is provided as a
dose pack, consisting of a vial and a pre-filled syringe containing 2 mL of
diluent for IM use. All formulations require room temperature storage.
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Approval date
Reclast®
(zoledronic acid)
Novartis
IV infusion
Approved: 8/17/07
Indication
For reducing
the incidence
of bone
fracture in
women with
postmenopaus
al osteoporosis
Therapeutic Considerations
Affected Population
A 3rd generation bisphosphonate. Zoledronic acid is the same ingredient
found in Zometa® which is used for hypercalcemia of malignancy. Reclast
was approved earlier in 2007 for Pagets Disease. It will compete with oral
therapies such as Actonel® (risedronate) and Fosamax® (alendronate) and
with oral and intravenous Boniva® (ibandronate). Intravenous Boniva® is
administered every 3 months.
Costs
(AWP)
Postmenopausal
$1,041 per
osteoporosis
dose
(osteoporosis) is a
serious condition
affecting millions of
women worldwide.
An estimated one out
Efficacy:
of every two women
Phase III data demonstrated that zoledronic acid 5 mg was highly effective in over age 50 with
reducing the incidence of bone fracture in women with postmenopausal
osteoporosis will
osteoporosis across the most common fracture sites -- hip, spine and nonsuffer an
spine -- with sustained effect over three years. Further data demonstrated
osteoporotic fracture
that postmenopausal osteoporosis patients currently taking oral alendronate in her lifetime. Of
can be directly switched to zoledronic acid and maintain beneficial bone
those women age 65
effects for a full 12 months after a single dose.
years or older who
fracture a hip, 21%
An interim analysis from the three-year HORIZON Pivotal Fracture Trial
will die within one
showed that patients treated with zoledronic acid 5mg experienced a 70%
year.
risk reduction in new spine fractures (p<0.0001) and a 40% risk reduction in
hip fractures (p=0.0032) over three years compared to placebo.
Safety:
Side effects include: fever and chills; muscle, bone or joint pain; nausea;
fatigue; and headache. Most are mild and occur within 3 days after dosing.
Zoledronic acid may cause hypocalcemia. It is not recommended in severe
renal impairment (creatinine clearance <35mL/min). Osteonecrosis of the
jaw has been reported in patients treated with bisphosphonates including
zoledronic acid. Pregnancy Category D.
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Dosing: 5 mg / 100 mL IV each year. To reduce hypocalcemia, patients
should receive 1500 mg calcium and 800 IU vit. D daily, particularly 2 weeks
following first dose.
How supplied: 5mg zoledronic acid in 100mL requiring room temperature
storage. An opened vial is stable under refrigeration for 24 hours.
Lyrica™
(pregabalin)
oral
Pfizer
(priority review)
New indication
approved: 6/21/07
For the relief of
pain and other
symptoms
associated with
fibromyalgia
Pregabalin was previously approved for use in diabetic peripheral neuropathy Fibromyalgia is
$2.18 per
(DPN), post herpetic neuralgia (PHN) and as adjunctive therapy for partial
marked by prolonged dose
onset seizures. Pregabalin is a Schedule V controlled substance.
or chronic pain, as
well as muscle
Efficacy:
stiffness and
The efficacy of pregabalin for fibromyalgia was established in a 14-week,
tenderness and
double-blind, placebo-controlled, multicenter study (F1) and a six month,
affects about 3
randomized withdrawal study (F2). Enrolled patients had a history of pain for million to 6 million
3 months, and pain present at 11 or more of 18 specific tender point sites.
people in the U.S.
each year, FDA
In Study F1, 529 women completed a 1-week baseline phase, after which
says, noting the
they were randomized to 8 weeks of placebo or one of three doses of
disorder mainly is
pregabalin (150, 300, or 450 mg daily). Among all pregabalin groups, 48%
seen in women and
had a 30% reduction in pain, vs. 27% of placebo (P <0.001). Among women develops in early-toon pregabalin 450mg daily, 29% had a >50% reduction in pain vs. 13% of
middle adulthood.
placebo (P = .003). Average sleep quality, fatigue, and patient global
assessment (PGIC), and Fibromyalgia Impact Questionnaire (FIQ) scores
were significantly improved vs baseline for pregabalin 300mg and 450mg.
Study F2: In this randomized withdrawal study, doses were titrated during a
6-week open-label phase to 300mg, 450mg, or 600mg daily of pregabalin or
placebo. Patients were considered to be responders if they had both: 1)
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Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
≥50% reduction in pain (VAS) and, 2) rated PGIC as "much or very much
improved". Responders were then randomized to treatment for up to 6
months. Efficacy was assessed by time to loss of response, defined as 1)
<30% reduction in pain (VAS) from phase 1, or 2) worsening of symptoms
requiring alternative treatment. In this phase, 38% of patients completed 26
weeks of pregabalin vs 19% of placebo-treated patients. 53% on pregabalin
maintained a response to Week 26 vs. 33% on placebo.
Safety:
The most common adverse events were dizziness (38%), somnolence
(20%), dry mouth (8%), edema (6%), blurred vision (8%), weight gain, and
concentration difficulty (5%). Angioedema or hypersensitivity reactions can
occur. Increased seizure frequency may occur in those with seizure
disorders if the agent is rapidly discontinued. Pregnancy Category C.
Dosage: Begin at 150 mg/day in 2 divided doses/day with or without food. .
May be increased to 300 mg/day within 1 week. Max dose of 450 mg/day.
How supplied: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and
300mg in bottles of 90 capsules requiring room temperature storage.
Fragmin®
(dalteparin sodium)
Subcutaneous
Injection
Eisai, Inc.
for the
extended
treatment of
symptomatic
venous
thromboemboli
sm (VTE)
[proximal deep
Previously Fragmin was indicated for prevention of DVT in patients
undergoing hip replacement, abdominal surgery and in acutely ill patients
whose mobility is severely restricted. Fragmin is also approved for
prophylaxis of ischemic complications from unstable angina and non-Q-wave
myocardial infarction.
Patients with cancer 10,000IU
have a 4-fold
syringe =
increased risk of
$64.80
VTE vs. the general
population, for an
annual incidence of
Efficacy:
~0.48%. Cancer
In a prospective, multicenter trial (CLOT), 676 patients with cancer and acute patients are also at
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Drug
Manufacturer
Route
Approval date
Pfizer, Inc.
Approved: 5/2/07
Singulair®
(montelukast)
Merck
Oral
Indication
Therapeutic Considerations
vein
thrombosis
(DVT) and/or
pulmonary
embolism (PE)]
to reduce the
recurrence of
VTE in patients
with cancer.
deep vein thrombosis (DVT) and/or pulmonary embolism (PE) were studied.
Patients were randomized to dalteparin 200 IU/kg/day SQ x 1 month then
150 IU/kg/day SQ for five months or dalteparin 200 IU/kg/day SQ for 5-7
days and oral anticoagulant (OAC) for 6 months. Results: a total of 27 (8.0%)
and 53 (15.7%) patients in the dalteparin and OAC arms, respectively,
experienced at least one episode of symptomatic DVT and/or PE during the
6-month study period. Most of the difference occurred during the first month
of treatment. The benefit was maintained over 6-months. Mortality rates were
similar between the study groups at the end of the study.
Safety: The most commonly reported side effect is hematoma at the
injection site. Pregnancy category B.
For the
prevention of
exerciseinduced
bronchoconstri
ction (EIB).
Montelukast was previously approved for asthma and seasonal or perennial
allergic rhinitis (SAR, PAR). It is the first oral therapy approved for EIB.
Affected Population
Costs
(AWP)
increased risk of
VTE because of
surgery,
chemotherapy,
radiotherapy, and
use of central
catheters. Patients
undergoing therapy
for breast cancer can
have VTE rates as
high as 9%. The
incidence of DVT in
Dosing: First 30 days: 200 IU/kg subcutaneously (SQ) once daily. Months cancer patients
2-6: 150 IU/kg, SQ once daily. The daily dose should not exceed 18,000 IU. undergoing surgery
ranges from 20% to
How Supplied:
40%, and the risk of
In prefilled syringes: 2,500 IU/0.2mL; 5,000 IU/0.2mL; 7,500IU/0.3mL;
a fatal PE is
10,000IU/0.4mL; 10,000IU/1mL; 12,500IU/0.5mL; 15,000IU/0.6mL;
approximately 1%.
18,000IU/0.72mL; and in multiple dose vials: 95,000IU/3.8mL;
95,000IU/9.5mL. Store at room temperature 20°-25°C (68°-77°F).
EIB is a condition
$3.44 per
typically found in
tablet
patients with asthma.
Efficacy:
During
Efficacy of montelukast 10 mg, given as a single dose 2 hours before
bronchoconstriction
exercise for EIB was proven in 3 randomized, double-blind, placeboinduced by exercise,
controlled studies that included 160 patients. Exercise challenge testing was the smooth muscle
conducted at 2 hrs, 8.5 or 12 hrs, and 24 hrs after montelukast or placebo.
that surrounds the
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
New indication
approved:4/25/07
Indication
Therapeutic Considerations
Affected Population
The primary endpoint was mean maximum % fall in FEV1. A single 10mg
dose demonstrated a significant benefit against EIB when taken 2 hours prior
to exercise. The treatment difference % for montelukast vs placebo at 2, 8.5
and 24 hrs was -9%, -5% and -4% respectively.
airways in the lungs
contracts, narrowing
the airways and
blocking the flow of
air.
Costs
(AWP)
Safety:
Most common side effects occurring ≥ 2% were: pharyngitis, influenza, fever,
sinusitis, nausea, diarrhea, dyspepsia, otitis media viral infection, laryngitis,
upper respiratory infection, wheezing, tonsillitis, cough; and rhinitis.
Dosing:
A dose at least 2 hours before exercise. An additional dose should not be
taken within 24 hours of a previous dose.
How supplied: 10mg tablets are supplied in bottles of 30, 90, 8,000 and
blister packs of 100 requiring room temperature storage.
Keppra®
(levetiracetam)
UCB Pharma
Oral
New indication
approved: 3/21/07
For treatment
of primary
generalized
tonic-clonic
(PGTC)
seizures in
adults and
children 6
years of age
and older with
idiopathic
generalized
This new indication is the fourth for Keppra tablets and oral solution in the
US, and the second for a generalized seizure type.
In epidemiological
$6 - $18
studies generalized per day.
seizures account for
Efficacy:
about 40% of
In a multicenter, randomized, double-blind, placebo-controlled clinical trial of incidence cases, with
Keppra as add-on treatment in 164 patients (four-65 years of age) with
generalized tonicrefractory IGE, 24.1% achieved complete seizure freedom over the 20 week clonic seizures
evaluation vs. 8.3% on placebo in addition to their usual treatment (p=0.009). estimated at 23%.
72.2% on Keppra achieved a 50% reduction in weekly PGTC seizures vs.
45.2% on placebo (p < 0.001).
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Drug
Manufacturer
Route
Approval date
Indication
epilepsy (IGE)
Therapeutic Considerations
Affected Population
Costs
(AWP)
Safety:
In the trial discussed above, the most common adverse event was
nasopharyngitis (14% Keppra vs. 5% placebo). Pregnancy category C.
Dosing:
Adults 16 Years And Older: initiate with 500 mg BID. Dosage should be
increased by 1000 mg/day every 2 weeks to a daily dose of 3000 mg.
Pediatric Patients Ages 6 To <16 Years: initiate with a daily dose of 10 mg/kg
BID. The daily dose should be increased every 2 weeks by 20 mg/kg to a
daily dose of 60 mg/kg (30 mg/kg BID).
How Supplied:
250, 500 and 750mg tablets in bottles of 120 tablets. 1000mg tablets in
bottles of 60 tablets. Oral solution, 100mg/mL in a 16oz bottle. Requires
room temperature storage.
Lipitor®
(atorvastatin)
Pfizer
Oral tablets
3/02/2007
In patients with
clinically
evident
coronary heart
disease,
Lipitor® is
indicated to:
• Reduce the
risk of non-fatal
MI
• Reduce the
risk of fatal and
Lipitor® was previously approved for :
Prevention of Cardiovascular Disease
In adult patients without clinically evident coronary heart disease, but with
multiple risk factors for coronary heart disease such as age, smoking,
hypertension, low HDL-C, or a family history of early coronary heart disease,
Lipitor® is indicated to:
• Reduce the risk of myocardial infarction
• Reduce the risk of stroke
• Reduce the risk for revascularization procedures and angina
The prevalence rate ~ $4 per
of coronary heart
day.
disease was
estimated to be > 13
million (1 in 20 or
4.85%) in the US in
2001. An estimated
1.2 million new or
recurrent coronary
attacks in the US
In patients with type 2 diabetes, and without coronary heart disease, but with occur each year.
risk factors for coronary heart disease such as retinopathy, albuminuria,
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Indication
non-fatal stroke
• Reduce the
risk for
revascularizatio
n procedures
• Reduce the
risk of
hospitalization
for CHF
• Reduce the
risk of angina
Therapeutic Considerations
Affected Population
smoking, or hypertension, to Reduce the risk of myocardial infarction and
Reduce the risk of stroke
Hypercholesterolemia
Lipitor® is indicated:
1. to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase
HDL-C in primary hypercholesterolemia and mixed dyslipidemia (Fredrickson
Types IIa and IIb);
2. as an adjunct to diet for the treatment of patients with elevated serum TG
levels(Fredrickson Type IV);
3. for primary dysbetalipoproteinemia (Fredrickson Type III);
4. for homozygous familial hypercholesterolemia as an adjunct to other lipidlowering therapy;
5. to reduce total-C, LDL-C, and apo B levels in children, 10 to 17 years old,
with heterozygous familial hypercholesterolemia
Efficacy:
The new indications were based on the five-year Treating to New Targets
(TNT) study comparing 80mg and 10mg atorvastatin in 10,001 patients with
heart disease who had reached a target LDL-C level of <130 mg/dL. In the
study, patients receiving Lipitor 80mg had a 22% reduction in the relative risk
of major CV events vs. 10mg. Patients also had a 26% reduction in the risk
of hospitalization for heart failure (HF). Lipitor 80 mg/day significantly
reduced the rate of nonfatal, non-procedure related MI and fatal and nonfatal
stroke, but not CHD death or resuscitated cardiac arrest.
For the secondary endpoints, 80 mg Lipitor significantly reduced coronary
revascularization, angina and hospitialization for HF, but not peripheral
vascular disease.
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Costs
(AWP)
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
There was no difference between the treatment groups for mortality. The %
who experienced cardiovascular death, including the components of CHD
death and fatal stroke were smaller with 80 mg vs. 10 mg.
The new approvals were supported by the IDEAL study, which compared
Lipitor 80 mg to simvastatin (Zocor) 20 mg to 40 mg in 8,888 patients with a
history of CHD to assess reduction in CV risk. Patients were followed for a
median of 4.8 years. There was no significant difference between treatments
for the primary endpoint (rate of first coronary event). The rate in the Lipitor
80 mg group was 9.3% (411), vs. 10.4% with simvastatin 20 mg-40 mg (463).
As in the TNT trial, there were no significant differences between groups in
all-cause mortality: 8.2% (366) for Lipitor versus 8.4% (374) for simvastatin.
Safety:
In the TNT trial, there were more serious adverse events at 80 mg vs. 10 mg.
Persistent transaminase elevations occurred in 62 (1.3%) patients on 80 mg
and nine (0.2%) on 10 mg. Elevations of CK were higher at the 80mg dose
(13, 0.3%) vs. 10mg (6, 0.1%).
Dosing: The dosage range is 10 to 80mg once daily administered as a single
dose at any time of the day, with or without food.
How Supplied: 10 and 20mg in bottles of 90 and 5000 tablets; and 40 and
80mg tablets in bottles of 90 and 500 tablets requiring room temperature
storage.
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Costs
(AWP)
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Humira®
(adalimumab)
IV injection
Abbott
New Indication
Approved:
02/27/2007
Indication
For reducing
the signs and
symptoms and
inducing and
maintaining
clinical
remission in
adults with
moderately to
severely active
Crohn's
disease who
have had an
inadequate
response to
conventional
therapy. It is
indicated for
reducing signs
and symptoms
and inducing
clinical
remission in
these patients
if they have
also lost
response to or
are intolerant to
infliximab
Therapeutic Considerations
Affected Population
This is a new indication for Humira. Humira will compete with infliximab
Crohn's disease
(Remicade) for treatment of Crohns disease. Unlike Remicade, Humira is not affects approximately
indicated for pediatric patients with Crohns disease.
500,000 Americans.
Most patients are
Efficacy:
usually diagnosed
Data from CHARM, the Crohn's trial of Human antibody Adalimumab for
before age 30.
Remission Maintenance, showed remission rates maintained through 56
weeks in patients who demonstrated response to Humira during a 4-week
open-label phase. Clinical remission was measured by a decrease in the
Crohn's Disease Activity Index (CDAI).
Costs
(AWP)
Starter
pack =
$4,951
Pen or
syringe =
$1,650
Of 172 patients treated with Humira every other week, 40% were in clinical
remission at week 26 (p<0.001) and 36% were in remission at week 56
(p<0.001). Of the 157 patients taking Humira weekly, 46% achieved clinical
remission from Crohn's disease at week 26 (p<0.001) and 41% maintained
remission at week 56 (p<0.001). In comparison, of the 170 patients receiving
placebo, 17% achieved remission at week 26; 12% maintained remission at
week 56.
CLASSIC II (CLinical assessment of Adalimumab Safety and efficacy
Studied as Induction therapy in Crohn's) was a randomized, double-blind,
placebo-controlled, multi-center study. The trial included 220 patients who
had participated in the original CLASSIC study but were not in remission at
week 0 and week 4 of CLASSIC II. The standard dose for this cohort was
open-label treatment with 40 mg of Humira every other week (eow), the
same recommended dose used for Humira in rheumatoid arthritis. Patients
experiencing flares or persistent non-response to the standard dose were
given 40 mg of Humira every week. Of the 220 patients entering the study,
33% achieved clinical remission. Of the 156 patients completing 24 weeks of
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Drug
Manufacturer
Route
Approval date
Indication
(Remicade®).
Therapeutic Considerations
Affected Population
Costs
(AWP)
therapy, 78% achieved a response, with a decline in CDAI of at least 70
points, and 70% achieved a CDAI decline of at least 100 points, compared to
their baseline CDAI scores in CLASSIC.
Safety: The adverse events in the study were mild to moderate in severity
and similar to those observed in previous studies with patients with
rheumatoid arthritis. The most common serious adverse events were
exacerbations of Crohn's disease and infections.
Dosing: 160 mg initially at Week zero, 80 mg at Week 2, followed by a
maintenance dose of 40 mg every other week beginning at Week 4. Initial
dose may be given as 4 injections on 1 day, or divided over 2 days.
How Supplied:
Crohn’s Disease Starter Package containing 6 dose trays. Each dose tray
consists of a 1 mL prefilled glass syringe pen with a fixed 27 gauge ½ inch
needle, providing 40 mg (0.8 mL). Also available as 40 mg/0.8 mL in a
single-use prefilled pen syringe. Refrigeration storage is required.
Cymbalta®
(duloxetine)
Oral
Eli Lilly
New indication
approved: 2/23/07
For treatment Cymbalta is currently indicated for diabetes-related neuropathy and major
of generalized depressive disorder. Cymbalta will compete with other anti-anxiety agents
anxiety
that include SSRI agents and benzodiazepines (i.e. lorazepam, others).
disorder (GAD)
Efficacy:
Efficacy was established in 311 patients with major depression in a
multicenter, double-blind, placebo-controlled study. After one week, patients
were randomized to duloxetine 60 mg once daily (n=207) or placebo (n=104)
for 8 weeks. At the end of the study, patients entered a one-week, doubleblind discontinuation phase where the dose of the study medication was
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Every year 4 million $4.20 per
Americans are
capsule.
diagnosed with
generalized anxiety
disorder, the majority
of them women.
Patients with
generalized anxiety
disorder experience
symptoms like
70 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
tapered. A secondary analysis measured anxiety using anxiety items 10
(psychic) and 11 (somatic,) and the anxiety/somatization subscale of the
HAMD17. Patients < 75 experienced significant improvements in both
psychic anxiety symptoms, such as worry and tension, and physical anxiety
symptoms, as measured by the anxiety/somatization subscale, vs. those
treated with placobo. Patients 75 and older showed significant
improvements in psychic anxiety. They also showed a numerical advantage
on the anxiety/somatization subscale that was not statistically significant, vs.
placebo. The effectiveness of duloxetine in long-term use for GAD, (more
than 10 weeks), has not been systematically evaluated in controlled trials.
exaggerated worry or
chronic anxiety and
irritability. The illness
also tends to be
chronic with periods
of exacerbation and
remission.
Costs
(AWP)
Safety: Common adverse events: nausea (20%), dry mouth (15%),
constipation (11%), insomnia (11%), dizziness (9%), fatigue (8%),
somnolence (7%) and decreased appetite (8%). Pregnancy category: C.
Dosing: 60 mg once daily without regard to meals. For some patients, it may
be desirable to start at 30 mg once daily for 1 week. The safety of > 120 mg
once daily has not been adequately evaluated.
How Supplied: 20mg delayed-release capsules in bottles of 60. 30mg and
60mg delayed-release capsules in bottles of 30, 90 and 1000 requiring room
temperature storage.
Sutent®
(sunitinib)
Pfizer
For first-line
treatment of
advanced renal
cell carcinoma
(RCC)
Sunitinib was previously approved for gastrointestinal stromal tumor after
disease progression on or intolerance to imatinib mesylate. Sunitinib will
compete with aldesleukin (Proleukin®), sorafenib (Nexavar®) and interferon
alfa -2a and 2b.
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Advanced renal cell 50mg =
carcinoma (RCC) is $283
a relatively rare,
therapy-resistant
tumor. According to
the American Cancer
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Oral
New first-line
indication approved:
2/8/07
Indication
Therapeutic Considerations
Affected Population
Efficacy:
Efficacy was established based on a trial which included 750 treatment-naive
patients with metastatic RCC receiving either Sunitinib or interferon-alfa (IFN
infinity), the current standard of care. Patients on sunitinib achieved a median
progression-free survival of 11 months - more than double the five-month
median progression-free survival observed with the comparator.
Society, the rate of
people developing
kidney cancer has
been increasing
every year. In 2007,
an estimated 51,190
new cases of RCC
will be diagnosed
(31,590 in men and
19,600 in women) in
the US, and about
12,890 people will
die from RCC.
Safety: Common treatment-related adverse events included fatigue,
diarrhea, nausea, altered taste, mucositis/stomatitis, hypertension, anorexia
and bleeding.
Dosing: 50mg orally once daily with or without food, on a schedule of 4
weeks on treatment followed by 2 weeks off.
How Supplied: 12.5, 25, and 50mg capsules in bottles of 30 requiring room
temperature storage.
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Costs
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New Drug Approvals – 2007
Selected New Combinations/Formulations:
Drug
Manufacturer
Route
Approval date
Pantoprazole enteric
coated granules
(Protonix® For
Delayed-Release
Oral Suspension)
Wyeth
Oral granules
Approved:
11/14/07
Indication
For short-term
treatment of
erosive
esophagitis;
for maintenance
of healing of
erosive
esophagitis and
gastroesophage
al reflux
disease
(GERD);
for treatment of
hyper-secretory
conditions,
including
Zollinger-Ellison
syndrome.
Therapeutic Considerations
Affected Population
Costs
(AWP)
An enteric coated granule form of pantoprazole which can be given orally
in applesauce or apple juice, or through a nasogastric (NG) tube.
Dyspepsia is a
Not
digestive condition available
that affects
Efficacy:
approximately one
The Delayed-Release Oral Suspension has been shown to be equal to
in four Americans.
pantoprazole tablets in suppressing pentagastrin-stimulated maximum acid GERD
output in patients with GERD and a history of erosive esophagitis.
(gastroesophageal
reflux disease)
Safety:
affects
The adverse event profile for pantoprazole delayed-release oral
approximately 20
suspension is similar to the established safety profile of the delayedpercent of the U.S.
release tablets. The most common adverse events reported were:
population on a
headache (5%), abdominal pain (3%), liver function tests abnormal (2%), weekly basis.
nausea (2%), and vomiting (2%). Pantoprazole is pregnancy category: B.
Dosing: The oral dose is 40 mg once daily approximately 30 minutes prior
to a meal, administered in applesauce or apple juice and not in water or
other liquids, or foods. The granules for oral suspension should not be
split, chewed or crushed.
How Supplied: Enteric coated granules in a 40 mg unit dose packet in a
box of 30 packets. Requires room temperature storage.
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Indication
Brimonidine / timolol For the reduction
ophthalmic solution of intraocular
pressure (IOP) in
(Combigan™)
glaucoma or
ocular
Allergan
hypertension in
patients who
Ophthalmic
require
adjunctive or
Approved: 10/31/07 replacement
therapy due to
inadequately
controlled IOP.
Therapeutic Considerations
Affected Population
Costs
(AWP)
Combigan combines Allergan's Alphagan (brimonidine tartrate ophthalmic
solution 0.2%) and timolol ophthalmic solution 0.5%, a beta-blocker, both
of which are known to reduce intraocular pressure in patients with
glaucoma or ocular hypertension. These two agents are available as
Aphagan P (brimonidine, 0.1% and 0.15%) Betimol (timolol hemihydrate
0.25% and 0.5%) and timolol maleate generic (solution, 0.25% and 0.5%
dosed BID or gel dosed once daily).
Glaucoma, a group 5mL ($71);
of eye diseases
10mL ($154)
characterized by
damage to the
optic nerve, is a
leading cause of
preventable
blindness in the
Efficacy:
US. It is estimated
The combination brimonidine and timolol admistered BID was compared in that more than 3
trials to brimonidine 0.2% administered TID alone, timolol 0.5% dosed BID million Americans
alone and the combination of the agents dosed concomitantly as TID and have glaucoma,
BID dosing respectively. The combination provided an additional 1 to 3
but only half of
mmHg decrease in IOP compared to brimonidine alone and an additional those know they
decrease of 1 to 2 mmHg compared to timolol alone. However, the
have it. The total
combination administered BID was less effective (by 1 to 2 mmHg) in
number of
lowering IOP vs. the combination of the drugs administered TID and BID glaucoma cases
respectively.
worldwide is
estimated to be 65
Safety:
million. One of the
Brimonidine with timolol is labeled with the same contraindications as the risk factors of
separate components: asthma, COPD, Sinus bradycardia; AV block; or
glaucoma is
CHF. The components in the combination may result in potentiation of
elevated IOP, or
vascular insufficiency, muscle weakness, or in the masking of
pressure inside the
thyrotoxicosis or hypoglycemia. In clinical trials of 12 months duration the eye. This high
most frequent adverse events with the combination were allergic
pressure distorts
conjunctivitis, conjunctival folliculitis, conjunctival hyperemia, eye pruritis, the shape and
burning and stinging. The combination is pregnancy category: C.
damages the optic
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Indication
Therapeutic Considerations
Dosing:
One drop in the affected eye twice daily approximately 12 hours apart.
Soft contact lenses should be removed prior to administration due to the
benzalkonium chloride content of the solution.
How Supplied:
Supplied in 5ml and 10mL bottles requiring protection from light and room
temperature storage.
Voltaren® Gel
(diclofenac topical
gel)
Novartis
Topical
Approved: 10/17/07
For the relief of
the pain of
osteoarthritis of
joints amenable
to topical
treatment, such
as the knees and
those of the
hands.
Affected Population
Costs
(AWP)
nerve. Maintaining
healthy IOP levels
may slow the
progression of the
disease and help
prevent loss of
vision.
Diclofenac 1% in a topical gel is a non-steroidal anti-inflammatory (NSAID)
drug. Its systemic absorption is 94% less than comparable oral diclofenac.
Currently, a 3% topical gel formulation is marketed as Solaraze which is
indicated for treatment of actinic keratosis.
The US CDC and Not yet
the Arthritis
available
Foundation report
that the number of
Americans with
Efficacy:
arthritis or chronic
The efficacy of diclofenac gel in osteoarthritis was evaluated in doublejoint symptoms in
blind, multicenter, placebo-controlled, parallel-group trials. Study 1 was a 2002 was
12-week trial. Patients were randomized to diclofenac gel (n=127) or
estimated at 70
vehicle gel (n=119). The dose was 4g, 4 times daily, on 1 knee (16 g per million (1 in 3
day). At week 12, the pain index (as assessed by patients using the
adults), twice the
WOMAC= Western Ontario and McMaster Universities Osteoarthritis Pain prevalence of
Subindex; 0=best; 100=worst) was 28 in the diclofenac group vs. 37 in the 1985. 10 million
vehicle group (adjusted difference=7; 95%CI: 1, 12). Study 2 evaluated
Americans have
the efficacy for osteoarthritis of the hand in an 8-week trial. Patients were arthritis of the
randomized to diclofenac (2g per hand, 4 times daily, on both hands (16 g knee. More than
per day)) (n=198) or vehicle (n=187). Pain at Week 6 on a visual analog
$65 billion is spent
scale from 0 to 100 was 40 in the diclofenac group vs. 47 in the vehicle
each year on
group (adjusted difference= 7; 95%CI: 1, 13).
medical expenses
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Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Safety:
and lost wages
Diclofenac gel carries a black box warning similar to all NSAID agents with related to arthritis.
regard to increased risk (including possible death) of serious
cardiovascular thrombotic events, and serious gastrointestinal events
including bleeding, ulceration, and perforation. Dicolfenac is
contraindicated for pain with coronary artery bypass graft surgery.
Warnings: Package labeling contains warnings similar to all NSAIDs
regarding potential increased liver enzymes, renal necrosis, hypertension,
fluid retention, anaphylactoid reactions, and skin events. The most
common events from topical use (incidence >2%) were application site
reactions, including dermatitis. Pregnancy Category: C.
Dosing: Total dose should not exceed 32g/day. The dose is measured on
a dosing card to 2g (upper extremities; no more than 8gm daily per single
joint) or 4g (lower extremeties; no more than 16gm daily per single joint)
dose and applied 4 times a day.
How Supplied: Tubes containing 100g gel (10mg of diclofenac per gram
or 1%), requiring room temperature storage.
Renvela™
(sevelamer
carbonate)
Genzyme
For the control of
serum
phosphorus in
patients with
chronic kidney
disease on
dialysis.
Sevelamer carbonate, a calcium-free, metal-free, non-absorbed phosphate
binder,.is a buffered form of sevelamer hydrochloride (HCl) (Renagel).
Renagel is dosed as one to four tablets three times daily with meals,
depending on serum phosphorus levels. Sevelamer carbonate may result
in reduced metabolic acidosis and potentially improve GI adverse events
compared to the HCl.
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Elevated serum
Not yet
phosphorus levels available
are common in
dialysis patients
and associated
with increased risk
of cardiovascular
76 of 120
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Drug
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Approval date
Oral
Approved: 10/19/07
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Efficacy:
morbidity and
The efficacy of sevelamer HCl (Renagel) is well established. The efficacy mortality.
of sevelamer carbonate was evaluated in a single 5 week cross-over study
comparing it with sevelamer HCl. Stage 5 CKD patients on hemodialysis
were enrolled. 79 patients received, in random order, sevelamer
carbonate 800 mg tablets and sevelamer HCl 800 mg tablets for eight
weeks each, with no intervening washout. Study dose during the crossover period was determined based on the sevelamer HCl dose during the
run-in period on a gram per gram basis. The phosphate levels at the end
of each of the two cross-over periods were similar. Average actual daily
dose was 6 g/day for both.
Safety: Adverse events in one study were: nausea (3%) and vomiting
(3%). In studies with sevelamer HCl, the most common events included:
vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%),
abdominal pain (9%), flatulence (8%) and constipation (8%). Cases of
fecal impaction and ileus, bowel obstruction and bowel perforation have
been reported. Pregnancy Category: C.
Dosing: Starting dose= one to two 800 mg tablets TID with meals;
adjusted by one tablet per meal in two week intervals to obtain serum
phosphorus target (3.5-5.5 mg/dL).
How Supplied: 800mg tablets in bottles of 270 tablets requiring room
temperature storage.
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Hycamtin®
(topotecan)
Oral
GSK
New
indication/formulation
Approved: 10/12/07
Indication
For treatment of
patients with
relapsed small
cell lung cancer
(SCLC).
Therapeutic Considerations
This agent is a topoisomerase I inhibitor previously available by injection
only. Topotecan IV is currently indicated for SCLC after failure of first-line
chemotherapy. Oral topotecan is rapidly absorbed with peak
concentrations occurring between 1 to 2 hours after administration. The
oral bioavailability of topotecan is about 40%.
Efficacy:
Oral topotecan was studied in patients with relapsed SCLC in a trial to
evaluate overall survival. The patients were prior responders to firstline
chemotherapy, were not considered candidates for standard IV
chemotherapy, and had relapsed at least 45 days from the end of first-line
chemotherapy. Patients were randomized to topotecan (n=71) 2.3
mg/m2/day administered for 5 days repeated every 21 days plus Best
Supportive Care (BSC) or BSC alone (n=70). Patients in the oral
topotecan plus BSC group received a median of 4 courses (range 1 to 10)
and maintained a median dose intensity of HYCAMTIN capsules, 3.77
mg/m2/week. The oral topotecan plus BSC arm showed a significant
improvement in overall survival vs. BSC alone (25.9 weeks (95% CI: 18.3,
31.6) vs. 13.9 weeks (95% CI: 11.1, 18.6) respectively), (Log-rank p =
0.0104).
Additionally, results from a large study conducted in extensive SCLC
disease showed that oral topotecan, combined with cisplatin,
demonstrated clinical activity similar to IV etoposide/cisplatin, the standard
of care.
Safety:
Topotecan carries a black box warning regarding a necessary baseline
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Affected Population
Costs
(AWP)
Lung cancer is the Oral is not
leading cause of
yet available
cancer death in the
US. In 2004, the
National Cancer
Institute estimated
that 174,000 new
cases would be
diagnosed and
160,440 deaths
would occur due to
the disease. Nonsmall cell lung
cancer is the most
common type,
accounting for
about 80% - 85%
of all lung cancer
cases. Only 14% of
all lung cancer
patients will be
alive 5 years or
more after
diagnosis. The
majority of NSCLC
cancers are
diagnosed in more
advanced stages.
78 of 120
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Indication
Therapeutic Considerations
neutrophil count of ≥1,500 cells/mm3 and a platelet count ≥100,000
cells/mm3. The most common adverse events were neutropenia (61%),
anemia (25%), and thrombocytopenia (37%), nausea (27%), diarrhea
(14%), vomiting (19%), fatigue (11%), and alopecia (10%). Pregnancy
Category: D.
Dosing:
2.3 mg/m2/day orally once daily for 5 consecutive days repeated every 21
days. Dose modification is necessary for patients with bone marrow
toxicity or diarrhea.
Affected Population
Costs
(AWP)
Five year survival
rates range from
15%-30% in stage
IIIA, 3% - 6% in
Stage IIIB, and
less than 1% in
stage IV.
How Supplied:
0.25mg and 1mg capsules in bottles of 10 capsules requiring room
temperature storage.
Terbinafine oral
granules
(Lamisil®)
Novartis
Oral
New dosage form
approved: 9/28/07
For the treatment
of tinea capitis, a
fungal infection
of the scalp, in
children ages 4
years and older.
The FDA approached Novartis for a formulation of terbinafine that was
palatable for children. The granules are manufactured using a tablet
compression process, followed by film-coating. The granules have a
diameter of 2.1mm and contain 4.7mg of terbinafine.
Griseofulvin is currently FDA approved for Tinea capitis (suspension is
available as a generic); although terbinafine and the azole antifungals are
also effective treatment. (i.e: fluconazole suspension is generic).
Efficacy:
Two multinational trials investigated the efficacy of terbinafine granules in
patients 4-12 years of age with tinea capitis. Both trials were of similar
design. Patients were randomized to terbinafine (n=852) or griseofulvin
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Tinea capitis most Not
commonly affects available
children and is
often characterized
by severe itching,
dandruff and bald
patches. It is a
persistent and
contagious fungal
infection that
usually does not
respond to topical
treatment.
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Therapeutic Considerations
Affected Population
Costs
(AWP)
(n=434) dosed by weight and given once daily for 6 weeks and then
followed for an additional 4 weeks. The primary efficacy endpoint was
complete cure (negative KOH, negative culture and absence of signs of
infection) at week 10. For all dermatophytes isolated, 45% of patients
receiving terbinafine achieved a complete cure compared to 39.2% treated
with griseofulvin. In one study, griseofulvin had a higher rate of cure
against M. canis vs. terbinafine (51.1% vs. 30.6%).
Safety:
Common (>3%) reported adverse events include: nasopharyngitis (10%),
headache (7%), pyrexia (7%), cough (6%), vomiting (5%), upper
respiratory tract infection (5%), upper abdominal pain (4%), and diarrhea
(3%). Cases of liver failure, some leading to death or liver transplant, have
occurred with the use of oral terbinafine. Changes in the ocular lens and
retina have been reported with terbinafine tablets however, none were
reported in trials with oral granules. Drug interactions are a consideration
with use of terbinafine. Pregnancy Category: B.
Dosing:
The dose is based on weight: for a weight of <25kg = 125mg; 25-35kg =
187.5mg; and for >35kg = 250mg. The entire contents of a dose packet
are sprinkled on a spoonful of non-acidic food (i.e: pudding or mashed
potatoes) and swallowed once a day for 6 weeks (dose based on weight).
How Supplied:
Supplied in cartons containing 14 laminated packets. Each packet contains
approximately either 30 or 45 granules, corresponding to a single total
dose of 125 mg or 187.5 mg requiring storage at room temperature.
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Olmesartan /
amlodipine
Indication
For the treatment
of hypertension
as second-line
(Benicar) / (Norvasc) therapy as a
monotherapy or
(Azor™)
in combination
with other
Daiichi
hypertension
Sankyo/Forest
drugs.
Oral
Approved: 9/27/07
Therapeutic Considerations
Affected Population
Costs
(AWP)
Azor™ is a fixed-dose combination of two antihypertensives, the calcium
channel blocker (CCB) amlodipine and the angiotensin receptor blocker
(ARB) olmesartan. Amlodipine plus olmesartan provides two
complementary mechanisms of action to lower blood pressure. Pfizer's
patent for Norvasc expires in fall 2007. This combination will compete with
other CCB/ARB or CCB/ACEI combinations marketed today: Exforge®
(amlidopine/valsartan) and Lotrel® (amlodipine/benazepril) which is
available as a generic.
Hypertension, also
known as high
blood pressure,
affects
approximately 72
million people in
the United States
and approximately
one billion
Efficacy: The efficacy of amlodipine/olmesartan was evaluated in an 8
worldwide. It is
week, multicenter, double-blind trial. Patients were randomized (n=1940) often difficult to
to one of 12 treatments: placebo, amlodipine 5mg or 10mg, olmesartan
control, and of
10mg, 20mg, or 40mg, or amlodipine/olmesartan 5/10mg, 5/20mg,
those diagnosed
5/40mg, 10/10mg, 10/20mg, and 10/40mg. Amlodipine/olmesartan was
with high blood
shown to produce significant mean reductions in seated systolic and
pressure, 64.9
diastolic blood pressure (BP). Amlodipine/olmesartan 5mg/20mg reduced percent do not
systolic/diastolic BP (placebo-adjusted mean change) by 20 mmHg/11
have the condition
mmHg. The highest combination dose (10mg/40mg) reduced systolic BP under control. The
an average of 30.1 mmHg and diastolic BP an average of 19.0 mmHg vs number of people
reductions of 19.7 mmHg systolic/12.7 mmHg diastolic for amlodipine
with high blood
10mg alone (placebo= 4.8/3.1 mmHg). Compared to amlodipine 10mg
pressure is
alone, this was a 53% greater reduction in systolic BP with combination
expected to reach
therapy. The effect was maintained throughout the 24-hour dosing interval. about 1.6 billion
Efficacy was not affected by history of previous antihypertensive therapy, worldwide by 2025.
presence or absence of diabetes, age, race or gender.
Safety: The overall incidence of adverse events on the combination of
drugs was similar to that seen with the individual components.
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Manufacturer
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Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Discontinuation occurred in 2.6% for the combination vs. 6.8% for placebo.
Edema is a known, dose-dependent adverse effect of amlodipine but not
of olmesartan. The placebo-subtracted incidence of edema during the 8wk trial was 24.5% with amlodipine 10mg monotherapy. The incidence
was reduced when 20mg (13.3%) or 40mg (11.3%) of olmesartan was
added to 10mg amlodipine. Other events include hypotension, rash,
pruritus, palpitation, urinary frequency, and nocturia. Pregnancy
Categories C (first trimester) and D (second and third trimesters).
Dosing: One tablet daily by mouth with or without food.
How Supplied: As amlodipine/olmesartan tablets in 5mg/20mg,
10mg/20mg, 5mg/40mg, and 10mg/40mg strengths in bottles of 30, 90,
and 1,000 tablets requiring room temperature storage.
ACAM2000™
smallpox vaccine
Acambis
Injection
Approved: 8/31/07
For active
immunization
against smallpox
disease for
persons
determined to be
at high risk for
smallpox
infection
This new smallpox vaccine is derived from the smallpox vaccine licensed
by FDA in 1931, Dryvax, which is in limited supply because it is no longer
manufactured. Unlike the previous vaccine, ACAM2000 is manufactured
using modern cell-culture techniques. It will only be made available for
inclusion in the Strategic National Stockpile.
Smallpox is a
highly ,serious
contagious and
often fatal disease
caused by the
A .variola virus
Efficacy:
person infected
The efficacy of the new smallpox vaccine was established in 2 multi-center with smallpox
trials. In both trials, patients were randomized to ACAM2000 (n=2244) or
develops a rash
Dryvax (n=737). Study 1 was conducted in patients who previously had not characterized as
been vaccinated with smallpox vaccine (naïve subjects). Study 2 was
The .raised pocks
conducted in patients who had been vaccinated >10 years previously. In
virus spreads
both trials, the co-primary efficacy endpoints were the proportion of
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Not
available for
commercial
use.
82 of 120
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Manufacturer
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Indication
Therapeutic Considerations
Affected Population
patients with a successful vaccination (defined as a major cutaneous
reaction on Day 7 or 10) and the geometric mean neutralizing antibody
titer (GMT) on Day 30. In Study 1, ACAM2000 was non-inferior to Dryvax
in the % of vaccination successes (96% vs. 99%, respectively). In Study
2, the % of patients vaccinated with ACAM 2000 vs. Dryvax favored the
latter therapy (84% vs. 98% respectively). The GMT results with ACAM
2000 and Dryvax were the following: Study 1: 166 and 255; Study 2: 286
and 445, respectively. ACAM2000 was found to be non-inferior in Study 2
only.
easily through
body fluids and
contaminated
Routine .clothing
vaccination of the
public was
1972stopped in
after the disease
was eradicated
A .from the US
large proportion of
the population has
no immunity and
fatality rates could
be higher than
if smallpox %25
were to be
released as a
bioterrorist
.weapon
Safety:
Smallpox vaccine carries a black box warning regarding myocarditis and
pericarditis (rate of 5.7 per 1000 primary vaccinees (95% CI: 1.9-13.3)),
encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia,
generalized vaccinia, severe vaccinial skin infections, erythema multiforme
major (including Stevens-Johnson Syndrome), eczema vaccinatum, ocular
complications and blindness and fetal death. Common adverse events
include inoculation site reactions (97%), lymphadenitis (57%), and
constitutional symptoms, such as malaise, fatigue, fever, myalgia, and
headache (48%). These adverse events are less frequent in revaccinated
than those receiving the vaccine for the first time. Inadvertent inoculation
at other sites (face, nose, mouth, lips, genitalia and anus) is a complication
of vaccinia vaccination. Self-limited skin rashes including urticaria and
folliculitis, may occur following vaccination.
Costs
(AWP)
Dosing:
A droplet is administered by the percutaneous route (scarification) using
15 jabs of a bifurcated needle.
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Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Re-vaccination may be recommended (e.g. every 3 years).
How Supplied:
Supplied in multiple-dose 3 mL vial containing lyophilized powder. The
vaccine requires frozen storage; however itretains a potency for at least 18
months when stored under refrigeration. Reconstituted vaccine may be
stored in a refrigerator no longer than 30 days.
ACAM2000 will not be available to the public commercially. It has been
purchased by the federal government for inclusion in the Strategic National
Stockpile, for distribution by the Department of Health and Human
Services if needed.
Zingo™
for use on intact
skin to provide
(lidocaine powder)
local analgesia
prior to
Anesiva/Corgentech venipuncture or
peripheral
Topical
intravenous
cannulation in
Approved: 8/17/07
children 3-18
years of age.
This lidocaine powder device is a needle-free system that delivers
lidocaine powder into the epidermis (top layer of skin) and provides
analgesia in one to three minutes after administration. This rapid onset
may be especially useful in pediatric patients and emergency rooms. This
agent will compete with EMLA Cream (lidocaine 2.5% and prilocaine
2.5%), which is available as a generic. EMLA cream is applied one hour
prior to a procedure.
More than 18
million pediatric
procedures
involving gaining
venous access or
IV insertions or
blood draws are
performed each
Efficacy:
year in U.S.
The efficacy of lidocaine powder in patients 3–18 years was evaluated in 2 hospitals.
randomized, double-blind, controlled trials in which pediatric patients
received either lidocaine powder or a sham placebo device. All patients
required peripheral venipuncture or intravenous cannulation as part of their
clinical care. Zingo™ or a placebo device at the back of hand or
antecubital fossa, between one and three minutes prior to venipuncture or
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Not yet
available
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Manufacturer
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Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
peripheral venous cannulation. Measurements of pain were made
immediately following the venous procedure. Efficacy was measured using
a modified version of the Wong-Baker FACES pain rating scale [a
categorical 6-point scale containing 6 faces ranging from 0 (“no hurt”) to 5
(“hurts worst”)].
In both studies, treatment with active drug resulted in less pain, from
venipuncture or peripheral IV cannulation, compared with placebo.
Study 1: The FACES Scale Score (adjusted mean) for lidocaine was 1.77
(n=292) vs 2.10 (n=287) with placebo (difference -0.33 with 95% CI (-0.58;
-0.08).
Study 2: The FACES Scale Score (adjusted mean) for lidocaine was 1.38
(n=269) vs 1.77 (n=266) with placebo (difference -0.39 with 95% CI (-0.65;
-0.13).
Safety: The most common adverse reactions (>5%) are skin reactions at
the site of administration: erythema, petechiae, edema.
Dosing: One 0.5 mg application to the site planned for venipuncture or
intravenous cannulation, one to three minutes prior to needle insertion.
Perform the procedure within 10 minutes after administration.
How Supplied: An intradermal injection system that contains 0.5 mg of
sterile lidocaine hydrochloride monohydrate in a single-use device.
Labeled cartons contain 12 sleeves requiring room temperature storage.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
LCP-FenoChol
(fenofibrate)
Indication
For the treatment
of hyperlipidemia
and hypertriglyceridemia.
LifeCycle Pharma
A/S / Sciele Pharma
Therapeutic Considerations
This formulation of fenofibrate in 120mg and 40mg dosage strengths
utilizes LifeCycle Pharma's Meltdose® technology which is designed to
provide enhanced absorption and greater bioavailability. This fenofibrate
product will have the lowest dosage strengths of fenofibrate available and
will compete with other fenofibrate products such as TriCor, Antara and
Triglide. The product will likely be released in the US in late 2007 or early
2008.
Oral
Efficacy and Safety: The efficacy and safety of fenofibrate are well
established and are expected to be similar with LCP-FenoChol as with
other available products.
Approved: 8/10/07
Dosing: One tablet daily.
How Supplied: No information was available at the time of this report.
Sanctura® XR
(trospium chloride)
Indevus
Oral
Approved: 8/6/07
overactive
bladder with
symptoms of
urge urinary
incontinence,
urgency and
urinary frequency
Sanctura XR is a new once daily formulation of Sanctura used for the
treatment of overactive bladder.
Efficacy
The efficacy of extended-release trospium was based on 2 Phase III,
randomized, double blind, placebo-controlled, 12-week trials. In the initial
601 patient trial trospiumER resulted in 2.81 fewer toilet voids/day
compared to baseline, while the placebo group reported a 1.99 drop in
toilet voids. Trospium ER resulted in a 78% median reduction in the
number of incontinence episodes/day vs. 56% with placebo. Dry mouth
was reported in 8.7% treated with trospium vs. 3% for placebo.
New Drugs - 2007
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Affected Population
The incidence of
dyslipidemia is
highest in patients
with premature
coronary disease
(CHD), which can
be defined as
occurring before
age 55 in men and
before 65 in
women. The
prevalence of
dyslipidemia is as
high as 80 to 88%,
compared to 40 to
48% in those
without CHD.
OAB is
characterized by
chronic, troubling
urinary symptoms,
including urinary
urgency
(immediate need to
pass urine), with or
without urge
incontinence
(involuntary
Costs
(AWP)
Not yet
available.
$4.04 per
capsule
86 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Results from the second trial were similar and showed that trospium
extended release therapy was superior to placebo in reduction of
frequency of urination (toilet voids) and reduction in number of urge
incontinence episodes. Patients treated with trospium extended release
experienced 2.5 fewer toilet voids per day compared to baseline
(p=.0009), vs. placebo patients with 1.8 fewer toilet voids per day
compared to baseline. Patients treated with trospium extended release
experienced an 83% median reduction in the number of incontinence
episodes per day (p<.0001), whereas, 52% of the placebo-treated patients
had the same effect. A low incidence of dry mouth was reported.
leakage of urine
with the feeling of
urgency), urinary
frequency (voiding
8 or more times in
a 24 hour period)
and nocturia
(awakening 2 or
more times at night
to void). OAB
treatment is
estimated to be
worth $1 billion
dollars and is
growing
approximately 30%
annually. OAB
affects
approximately 33
million Americans.
The incidence is
higher in women
and the elderly.
Safety:
Currently, all available anticholinergic drugs for OAB [oxybutynin (Ditropan
XL, Oxytrol) or tolterodine (Detrol LA)], treatment act nonselectively at
muscarinic receptors on the bladder as well as other tissue types, resulting
in side effects such as dry mouth, constipation, blurry vision, urinary
retention, and central nervous system side effects. In phase III clinical
studies, the most commonly reported side effects with trospium extended
release were dry mouth (10.7% for extended-release vs. 3.7% for placebo)
and constipation (8.5% trospium extended release; 1.5% placebo group).
Trospium does not cross the blood-brain barrier, and is not associated with
central nervous system adverse effects, which can occur with oxybutynin.
Trospium extended release has not been compared directly to long-acting
versions of oxybutynin (Ditropan XL, Oxytrol) or tolterodine (Detrol LA).
Costs
(AWP)
Dosing:
The dosing will likely be one 60mg dose per day; however, at the time of
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
this update, no information was available.
How Supplied:
There is no information on how the drug will be supplied at the time of this
update.
Evamist™
(estradiol MDTS)
Vivus/KV
Phamaceutical
Transdermal spray
Approved: 7/30/07
For vasomotor
symptoms
associated with
menopause.
Estradiol MDTS is a topical estradiol therapy supplied as a transdermal
spray delivery device. It is a low-dose estrogen-only treatment for
vasomotor symptoms associated with menopause. Estradiol is released
into the blood stream on a sustained basis over 24 hours. The
manufacturer may not launch this product until 2008. The topical estradiol
products available today include: estradiol transdermal patch (Estraderm
or generic), Estrogel, Estrasorb emulsion, Elestrin gel, and Divigel.
Approximately two Not yet
million American
available
women reach the
age of 50 each
year. Women
naturally enter into
menopause
between the ages
Efficacy and Safety: The efficacy and safety of topical estrogen are well
of 45 and 55;
established. The efficacy and safety of the topical spray are expected to
however, surgical
be similar to all other topical/transdermal estrogen products.
menopause may
happen at any age.
Dosing: Application once daily.
Symptoms include
hot flashes,
How Supplied:
discomfort or pain
Estradiol MDTS will be supplied as an alcohol-based solution packaged in during sexual
a vial fitted with a metered-dose pump with an opening that controls the
intercourse due to
distance, angle, and area of application of the spray. Each metered-dose vaginal atrophy
pump contains 8.1 mL and delivers 56 sprays of 90 mcL after priming.
(thinning of the
Each spray contains 1.53 mg estradiol. The package requires room
vagina), and
temperature storage.
changes in skin
and hair.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
CaloMist™
Indication
Maintenance of
vitamin B12
(cyanocobalamin)
concentrations
after
Fleming
normalization
with IM B12 in
Nasal spray solution patients with B12
deficiency who
Approved: 7/27/07
have no nervous
system
involvement
Therapeutic Considerations
Affected Population
Costs
(AWP)
This new formulation of cyanocobalamin nasal spray was approved under
the 505b2 pathway which does not require efficacy and safety data
specific to the new formulation. This product will compete with Nascobal
nasal spray which is dosed as one spray of 500mcg per single nostril per
week.
Many patients with $112.45 per
Vitamin B-12
18 mL Rx
deficiency do not
experience
symptoms. For
those who do,
Efficacy:
symptoms of
In 24 vitamin B12 deficient patients who were stabilized on IM B12, once vitamin B12
daily intranasal dosing for 8 weeks resulted in serum vitamin B12
deficiency can
concentrations that were within the target range (>200 ng/L) and
include fatigue,
slightly higher than those seen 2 to 4 weeks after IM B12. Twenty-three of weakness, sore
these 24 patients received 50 mcg of nasalspray daily for the duration of
tongue,
the trial; the remaining patient required doubling of the dose to 100 mcg
forgetfulness,
daily during the last week.
weight loss, lack of
coordination and
Safety: The safety of vitamin B12 is well established. Vitamin B12
difficulty walking.
concentrations must be monitored with therapy. Cyanocobalamin causes Left untreated,
optic nerve atrophy in patients with Leber’s disease. Anaphylaxis and
vitamin B12
angioedema have been reported with parenteral vitamin B12. Pregnancy deficiency may
Category: C.
lead to anemia,
intestinal problems,
Dosing: One spray in each nostril daily (25 mcg per nostril, total
and irreversible
daily dose 50 mcg). Or one spray in each nostril twice daily for patients
nerve damage.
with an inadequate response to once daily dosing.
How Supplied: Available in a bottle containing 18mL (25 mcg
cyanocobalamin per 0.1 mL) requiring room temperature storage. One
bottle delivers 60 total sprays.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Atralin™
Indication
For the relief of
symptoms
associated with
seasonal allergic
rhinitis in patients
≥ 2 years of age;
Treatment of
uncomplicated
skin
manifestations of
chronic idiopathic
urticaria in
patients ≥ 6
months of age.
This is an orally disintegrating (melt in your mouth) formulation of
fexofenadine. Fexofenadine tablets are available as a generic; the ODT
and the suspension formulations are currently not available as a generic.
Topical
Approved: 7/26/07
Aventis/ Ethypharm
Oral
Approved: July 26,
2007
Costs
(AWP)
This is a new gel formulation of tretinoin in a strength of 0.05%. This agent Although acne is
$159 per
will compete with Retin A Micro gel which is available as 0.1% and 0.04%. usually a self45gm tube
limited disorder
Efficacy and Safety: The efficacy and safety of topical tretinoin are well
primarily of
established. Pregnancy category: C.
teenagers and
young adults,
Dosing: Apply a thin layer once a day before bedtime.
about 10 to 20% of
adults have acne.
How Supplied: 45 gm tubes requiring room temperature storage.
Coria
(fexofenadine)
Affected Population
For treatment of
acne vulgaris.
(tretinoin gel, 0.05%)
Allegra® ODT
Therapeutic Considerations
As many as 40
$1.88 per
million in the US
tablet
suffer from
seasonal allergies,
Efficacy:
such as nasal
The efficacy of fexofenadine is well established. No specific clinical trials, congestion, watery
evaluating efficacy, were conducted with the ODT formulation.
eyes, runny nose,
sneezing and itchy
Safety:
throat. Symptoms
The most common adverse events (≥ 2%) were headache, back pain,
typically occur in
dizziness, stomach discomfort, pain in extremity, cough, upper respiratory the spring and fall.
tract infection, pyrexia, otitis media, vomiting, diarrhea, somnolence/fatigue Chronic Idiopathic
and rhinorrhea. Pregnancy category: C.
Urticaria (CIU) is
most commonly
Dosing: Fexofenadine ODT is intended for use in children 6 to 11 years
known as "hives of
old. The recommended dose is 30 mg twice daily. A dose of 30 mg daily is unknown origin"
recommended as the starting dose in pediatric patients with decreased
and is defined as
renal function.
the occurrence of
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
How Supplied:
30mg tablets in blister packs of 60 tablets requiring room temperature
storage.
Privigen™
For the treatment
of patients with
(immune globulin
primary immunointravenous (Human) deficiency (PI)
10%)
associated with
defects in
CSL Behring AG
humoral
immunity and the
Intravenous (IV)
treatment of
Chronic Immune
Approved: July 26,
Thrombo2007
cytopenic
Purpura (ITP).
Privigen is the first and only proline-stabilized IVIg that is always ready for
immediate use, requiring no refrigeration or reconstitution. There are
numerous IVIG products marketed; the brands that currently have
indications for both PI and ITP are: Polygam® (powder, 2% glucose);
Gamunex® (liquid, no sugars); Gammagard® S/D (liquid, 2% glucose); and
Carimune™ NF (powder, 5% sucrose).
Affected Population
daily, or almost
daily, wheals and
itching for at least
six weeks with no
obvious causes.
Primary immune
deficiencies (PI)
are a group of
disorders that
cause a
malfunction in the
immune system,
Efficacy:
keeping the patient
Efficacy was based on two pivotal open-label, prospective, multi-center
from fighting off
studies. One study was performed in the U.S. and Europe in subjects with infections. Patients
PI, and the other study was performed in Europe in subjects with chronic face repeated
ITP. In the PI study, 80 adult and pediatric subjects received Privigen
rounds of
every three or four weeks at doses ranging from 200 mg/kg to 888 mg/kg antibiotics and
for a maximum of 12 months. The annual rate of serious bacterial
hospitalizations.
infections (bacterial pneumonia, meningitis, sepsis, osteomyelitis, and
Infections can
visceral abscesses), the primary endpoint, was 0.08 infections per subject become lifeper year. Pneumonia was reported in three subjects, and visceral abscess, threatening.
osteomyelitis, and septic arthritis in one subject each. The annual rate of
Nearly 100 types of
any infections, a secondary endpoint, was 3.55 infections per subject per PIs exist. Most are
year.
inherited, but in
some cases the
In the ITP study, 57 subjects with a platelet count of less than or equal to cause is unknown.
New Drugs - 2007
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Costs
(AWP)
$540 per
50ml;
$1080 per
100ml;
$2161 per
200ml
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
20 x 10(9)/L received 1g/kg Privigen twice on each of two consecutive
days and were observed for 29 days. A total of 46, or 80.7% of subjects,
responded to Privigen therapy with an increase of platelet count to greater
than or equal to 50 x10(9)/L within seven days after the first study drug
administration. Hemolysis occurred in eight subjects treated with Privigen
in the ITP study. These cases all resolved uneventfully.
Infusions of
replacement
antibodies
(immune globulins)
can help
supplement the
immune system to
Safety:
prevent infection in
Adverse events were reviewed based on 1,038 injections given during the nearly 75% of
clinical trials. Because Privigen is made from plasma, the risk of
peopith disease
transmitting infectious agents, including viruses, and theoretically, the
tied to an antibody
Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. deficiency.
Privigen is contraindicated in patients with known anaphylactic or severe
Immune
hypersensitivity responses to Immune Globulin (Human). Patients with
Thrombocytopenic
severe selective IgA deficiency may develop anti-IgA antibodies that can
Purpura (ITP) is an
result in a severe anaphylactic reaction.
autoimmune
Boxed warning: Immune Globulin Intravenous Human (IGIV) products
disease in which
have been associated with renal dysfunction, acute renal failure, osmotic the immune
nephrosis, and death. While reports of renal dysfunction and acute renal
system attacks and
failure have been associated with the use of many of the licensed IGIV
destroys platelets.
products, those containing sucrose as a stabilizer accounted for a
Chronic ITP most
disproportionate share of the total. Privigen does not contain sucrose.
often occurs in
adults and lasts 6
Dosage: PI – 200 to 800mg/kg IV every 3 to 4 weeks.
months or longer.
Chronic ITP – 1 g/kg IV daily for 2 consecutive days, for a total of 2 g/kg.
In the U.S.,
approximately
How Supplied: Single-use vial containing: 5g/50mL; 10g/100mL;
200,000 people
20g/200mL solution. Stable for 24 months stored at room temperature.
have the disorder.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Exelon® patch
(rivastigmine)
Novartis
topical patch
New dosage form
approved: 7/6/07
Indication
For the treatment
of mild to
moderate
dementia of the
Alzheimer’s type
and mild to
moderate
dementia
associated with
Parkinson’s
disease.
Therapeutic Considerations
Affected Population
Costs
(AWP)
This is a transdermal patch formulation of rivastigmine. The oral
$7.04 per
The National
formulation was approved in 2000 and it is available in 1.5, 3, 4.5 and 6mg Parkinson
patch, all
capsules as well as an oral solution.
doses
Foundation says
that 1.5 mil.
Efficacy:
Americans suffer
Efficacy was demonstrated in a randomized, double-blind comparison.
from Parkinson's
Patients (n=1,195) were randomized to one of the following 4 treatments: disease, with
9.5 mg/24 hours, 17.4 mg/24 hours, 6 mg capsules BID or placebo. This
60,000 new cases
24-week study was divided into a 16-week titration phase followed by an 8- diagnosed
week maintenance phase. Efficacy was assessed with the cognitive
annually. Novartis
subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog; range estimates that 40%
0 - 70 higher scores = greater impairment) which examines aspects of
of Parkinson's
cognitive performance including memory, orientation, attention, reasoning, patients suffer from
language and praxis and the Azheimer’s Disease Cooperative Study PDD.
Clinical Global Impression of Change (ADCS-CGIC) scored as a 7-point
rating, ranging from a score of 1, indicating “markedly improved”, to a
About 4.5 million
score of 7, indicating “marked worsening”.
Americans have
Alzheimer's, a toll
At 24 weeks, the mean differences in the ADAS-Cog change scores for the expected to reach
rivastigmine-treated patients, compared to placebo, were 1.8, 2.9, and 1.8 a staggering 14
units for the patch 9.5 mg/24 hours, patch 17.4 mg/24 hours, and oral
million by 2050
capsule groups, respectively. The difference between each of these
with the graying of
groups and placebo was significant.
the population. It
gradually robs
Safety:
sufferers of their
The most commonly observed adverse events occurring at a frequency of memories and
at least 5% and at a frequency at least greater than placebo were nausea, ability to care for
vomiting and diarrhea. Other less common and sometimes serious
themselves,
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
adverse events have been reported. Weight should be monitored during
therapy. Extrapyramidal symptoms may appear or be exacerbated.
Pregnancy Category: B.
Affected Population
Costs
(AWP)
eventually killing
them.
Dosage:
One patch 4.6 mg/24 hours once daily. Maintenance Dose one patch 9.5
mg/24 hours once daily. A minimum of 4 weeks of treatment and good
tolerability with the previous dose should be observed before increasing
the dose.
How Supplied:
4.6 mg/24 hours: 5cm2 size containing 9 mg rivastigmine
9.5 mg/24 hours: 10cm2 size containing 18 mg rivastigmine in cartons
containing 30 patches requiring room temperature storage.
Exforge®
(Amlodipine /
valsartan)
Novartis
Oral
Approval: 6/21/07
For the treatment Exforge utilizes two complementary mechanisms of action through the
of hypertension. calcium channel blocker (CCB) amlodipine and the angiotensin receptor
blocker (ARB) valsartan. Exforge is expected to be available in late
This fixed
September 2007
combination drug
is not indicated Efficacy:
for the initial
Approval of amlodipine/valsartan was based on 5 controlled trials in more
therapy of
than 2,600 patients. A single daily dose of amlodipine/valsartan therapy
hypertension.
achieved an average reduction of 35.8 mmHg in systolic blood pressure
(BP) vs 31.8 mmHg in patients treated with a lisinopril/HCTZ combination.
Furthermore, 80% of patients treated with amlodipine/valsartan for 6
weeks reached a mean diastolic BP < 90 mmHg.
New Drugs - 2007
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More than 65
million Americans,
or one in three
adults, are
estimated to have
high blood
pressure, with
approximately 70%
of them not under
control. Among
people who are
treated for
hypertension,
Per tablet
(lowest dose
to highest):
$2.70,
$3.42,
$3.06, and
$3.88
94 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Safety:
Adverse events were generally mild and transient in nature. The events in
at least 2% (n=1437) vs. placebo included peripheral edema (5.4% vs.
3.0%), nasopharyngitis (4.3% vs. 1.8%), upper respiratory tract infection
(2.9% vs 2.1%) and dizziness (2.1% vs 0.9%). Orthostasis occurred in <
1% of patients.
Pregnancy Category C (first trimester) and D (second and third trimesters).
approximately 50%
are still estimated
not to have
achieved their
treatment blood
pressure goal.
Costs
(AWP)
Dosage:
Amlodipine is an effective in once daily doses of 2.5mg-10mg while
valsartan is effective in doses of 80mg-320mg. In clinical trials with the
combination (amlodipine plus valsartan) using amlodipine doses of 5mg10mg and valsartan doses of 160mg-320mg, the antihypertensive effects
increased with increasing doses. A patient whose blood pressure is not
adequately controlled with amlodipine (or another DHP
CCB) alone or with valsartan (or another ARB) alone may be switched to
this combination.
How Supplied:
Four dosage strengths: 5 mg amlodipine/160 mg valsartan, 10/160 mg,
5/320 mg and 10/320 mg are available in packages of 30 and 90 tablets
requiring room temperature storage.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Endometrin®
To support
embryo
implantation and
early pregnancy
by
supplementation
of corpus luteal
function as part
of an Assisted
Reproductive
Technology
(ART) treatment
for infertile
women.
(progesterone
vaginal inserts)
Ferring
Pharmaceuticals
Vaginal Insert
Approved: June 21,
2007
Therapeutic Considerations
Affected Population
Costs
(AWP)
This is a progesterone vaginal insert that provides targeted delivery of
progesterone at the uterine level. This is the first commercially available
progesterone suppository. The product will compete with progesterone
vaginal gel (Crinone® and Prochieve®).
In in-vitro
$137.03 per
fertilization (IVF), 21 pouches.
patients typically
begin progesterone
support on the day
Efficacy:
of egg retrieval and
Efficacy was based on a landmark, multicenter, randomized, open-label,
continue it until the
trial (n=1,211) of 100mg progesterone vaginal insert vs. active comparator. 10th week of
Efficacy was measured by continuing pregnancy and live birth rates. On
pregnancy.
the day of oocyte retrieval, patients were randomized to progesterone
Progesterone
vaginal insert 100 mg twice daily (BID), 100 mg three times daily (TID), or supplementation is
an active control (progesterone vaginal gel (90 mg) QD). In the study,
utilized by nearly
97% of patients randomized to participate received an embryo transfer.
all patients
undergoing
The results showed that progesterone insert 100mg was efficacious, with assisted
no significant differences in efficacy parameters between treatment arms. reproductive
It was not inferior to the active comparator. Continuing pregnancy rates
technology (ART)
were 44% with TID therapy and 40% with BID treatment. Live birth rates
and about 60% of
were also high: BID 36.5% vs. TID therapy 39.7%. The groups showed
ovulation induction
equivalent tolerability.
(OI) patients.
Safety:
In clinical trials, adverse events that occurred at a rate > or = 2% included:
uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation,
itching, burning or discomfort, urticaria, and peripheral edema were
reported at an incidence of <2%. Endometrin is expected to have a safety
profile similar to other drugs containing progesterone (breast tenderness,
bloating, mood swings, irritability, and drowsiness).
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Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Dosing: Vaginally two or three times daily, starting at oocyte retrieval and
continuing for up to 10 weeks total duration.
How Supplied:
The 100mg progesterone vaginal inserts are packaged individually in
sealed foil pouches. There are 21 pouches in each box requiring storage
at room temperature.
Lexiva®
(fosamprenavir
calcium)
Oral Suspension
GlaxoSmithKline
New formulation
approved: June 14,
2007;
Original tablets
approved 10/20/2003
For use in
combination with
other
antiretroviral
agents for the
treatment of
human immunodeficiency virus
(HIV -1) infection.
Fosamprenavir calcium is a prodrug of amprenavir, an inhibitor of human An estimated
immunodeficiency virus (HIV) protease. The tablet formulation of this drug 850,000-950,000
has been available since October 2003.
persons in the
United States are
Efficacy: Pediatric Patients
living with human
The approval of the suspension formulation was based on an open label
immunodeficiency
study in pediatric patients between 2-18 years of age. Twice-daily dosing virus (HIV),
regimens: fosamprenavir suspension with ritonavir (n=57, 27 therapyincluding 180,000naïve) or without ritonavir (n=18; 16 therapy-naive) were evaluated in
280,000 who do
combination with other antiretroviral agents.
not know they are
infected.
At Week 24, 67% of patients taking the suspension with ritonavir (12/18)
achieved HIV -1 RNA 0:400 copies/mL, and the median increase from
baseline in CD4+ cell count was 353 cells/mm3.
700mg
tablet =
$12.21 per
tablet
$117.25 per
Rx of
suspension
In the group assigned to fosamprenavir suspension without ritonavir, at
week 24, 70% of protease inhibitor-naive (19/27) and 57% of experienced
(17/30) patients achieved HIV -1 RNA 0:400 copies/mL; median increases
from baseline in CD4+ cell counts were 131 cells/mm3 and 149 cells/mm3
in protease inhibitor-naive and experienced patients, respectively.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Safety:
Fosamprenavir should be used with caution in patients with a known
sulfonamide allergy. In adults the most common adverse events (~4%)
are diarrhea, rash, nausea, vomiting, headache. Vomiting was more
frequent in pediatrics than in adults. Acute hemolytic anemia has been
reported with amprenavir. New onset or exacerbations of diabetes
mellitus, hyperglycemia, immune reconstitution syndrome, accumulation of
body fat, and elevated trglyceride concentrations have been reported.
Certain drugs should not be coadministered with fosamprenavir due to risk
of serious or life-threatening adverse reactions. Details regarding this and
other drug interactions associated with the use of fosamprenavir can be
found in the product labeling.
Patient populations at an increased risk of adverse effects are those with
hepatitis B or C (transaminase elevations), and hemophilia (spontaneous
bleeding). Pregnancy Category C.
Dosage:
Therapy-Naïve Adults: without food:
1,400 mg twice daily;
1,400 mg once daily plus ritonavir 200 mg once daily; 700 mg twice daily
plus ritonavir 100 mg twice daily
Protease Inhibitor-Experienced Adults: without food:
700 mg twce daily plus ritonavir 100 mg twice daily
Pediatrc Patients: with food:
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
(2 to 18 years of age): Dosage based on body weight (kg) and should not
exceed adult dose (1400mg BID).
Data are insuffcient to recommend:
 once-daily dosing, and
 use in therapy-experienced patients 2-5 years old
Therapy-Naive 2 to 5 Years of Age: with food:
30 mg/kg twice daily
Therapy-Naive::6 Years of Age: with food:
Either 30 mg/kg twice daily or 18 mg/kg plus ritonavir 3 mg/kg twice daily
not to exceed the adult dose of fosamprenavir 700 mg plus ritonavir 100
mg twice
daily.
Therapy-Experienced ~6 Years of Age:
18 mg/kg plus ritonavir 3 mg/kg administered twice daily not to exceed the
adult dose of 700 mg plus ritonavir 100 mg twice daily.
Hepatic Impairment: adjustments for patients with mild, moderate or
severe hepatic impairment
How Supplied:
700-mg tablets and 50-mg/mL oral suspension (grape-bubblegumpeppermint-flavored), equivalent to approximately 43 mg of amprenavir in
each 1 mL. Bottle of225 mL. The product does not require reconstitution.
Requires storage at 5° to 30°C (40° to 86°F).
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Extina® Foam, 2%
Indication
For topical
treatment of
(ketoconazole)
seborrheic
dermatitis in
Topical foam
immunocompete
nt patients 12
Stiefel Laboratories, years of age and
Inc.
older.
Approved: June 12,
2007
Therapeutic Considerations
This is a new foam formulation of ketoconazole 2%. It will compete with
generic ketoconazole 2% creams indicated for seborrheic dermatitis and
Xolegel (2% gel formulation) which is indicated for once daily treatment of
seborrheic dermatitis.
Affected Population
Seborrheic
dermatitis can
occur on many
body areas.
Typically it forms
Efficacy:
where the skin is
The efficacy of ketoconazole foam in seborrheic dermatitis was
oily. Commonly
established in a randomized, double-blind, study in 847 patients ≥12 years affected areas
of age. Patients were randomly assigned ketoconazole foam (n=427) or
include the scalp,
vehicle foam (n=420) to be applied twice daily for 4 weeks. The overall
eyebrows,
disease severity was assessed at baseline and week 4 on a 5-point
eyelids, creases of
Investigator’s Static Global Assessment (ISGA) scale. Treatment success the nose, behind
was defined as achieving a Week 4 ISGA score of 0 (clear) or 1 and at
the ears, and along
least two grades of improvement from baseline. 56% of patients treated skin folds. The
with ketoconazole achieved success (n=239) vs 42% receiving vehicle
cause is unknown.
(n=176).
Neurologic
conditions,
Safety:
including
The most common adverse events (incidence > 1%) were application site Parkinson's
reactions such as burning. Safety and efficacy of ketoconazole foam for
disease, and
treatment of fungal infections have not been established.
stroke, are
associated with
Dosage: Application twice daily for four weeks.
seborrheic
dermatitis.
How Supplied:
In 50g and 100g containers. The foam requires room temperature
storage; it should not be refrigerated.
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Costs
(AWP)
$155 per
50gm;
$289 per
100gm
100 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Divigel®
(estradiol 0.1% gel)
Upsher-Smith
Laboratories, Inc.
Topical gel
Approval: June 4,
2007
Indication
For the treatment
of moderate-tosevere
vasomotor
symptoms
associated with
menopause.
Therapeutic Considerations
Affected Population
Divigel is a new 0.1% fast drying estradiol gel, the same estrogen
produced naturally in women. This formulation offers the lowest estradiol
dosage in topical formulations. The starting dose of 0.25mg of Divigel is
equal to 0.325mg of estradiol valerate or 0.1mg of conjugated equine
estrogen. (Piippo, et al. (J Clin Endocrinol Metab 89: 3241–3247, 2004)
Three other topical estrogen products are available. The table below
compares the agents.
Product:
Divigel
0.1% gel
Elestrin
0.06% gel
Estrogel
0.06% gel
Estrasorb
Topical emulsion
Estradiol transdermal
dose of
base
product:
0.25 gm –
1 gm
Estradiol content:
"Systemic dose":
0.25 mg –
1.0 mg
NA
0.87 gm
0.52 mg
0.0125 mg
1.25 gm
0.75 mg
0.05 mg
4.35 mg
(as hemihydrate)
4 mg or 8 mg
0.025 mg per pouch,
0.05 mg per dose
0.05 mg or 0.1 mg
1.74 gm
One patch
NA= not available
Costs
(AWP)
According to the
$2.25 per
North American
dose
Menopause
Society, there are $68 per Rx
approximately 40
million women in
the United States
of menopausal
age. As many as
93 percent of
women going
through
menopause
experience
vasomotor
symptoms such as
hot flashes, which
can greatly impact
a woman's life.
The efficacy and safety of Divigel are expected to be similar to other
topical estrogen products.
Dosing:
Patients should be treated with the lowest effective dose. Dose should be
started at 0.25 gram daily. Subsequent dosage adjustments may be made
based upon response. Gel is applied once daily on the right or left upper
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Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
thigh. The area should be about 5 by 7 inches (approximately the size of
two palm prints).
How Supplied:
Supplied in boxes of 30, single-dose foil packets of 0.25, 0.5, and 1.0 g,
corresponding to 0.25, 0.5, and 1.0 mg estradiol, respectively. The
packets require room temperature storage.
Zyflo CR™
(zileuton controlledrelease tablets)
oral
For the
prevention and
chronic treatment
of asthma in
adults and
children 12 years
of age and older
Critical
Therapeutics/DEY
New formulation
approved: 5/31/07
Lybrel™
Low dose 365
day/year
(levonorgestrel 0.09 contraception
Zileuton inhibits formation of leukotrienes, mediators that trigger asthma.
According to the
$305.00 per
The dose of immediate release Zyflo, is one 600mg tablet four times a day. American Lung
bottle of 120
Association, ~20
tablets
Efficacy: The efficacy of zileuton was established with the immediate
million in the US
release formulation
have asthma.
Asthma can lead to
Safety: The most common adverse reactions (≥5%) included sinusitis,
symptoms such as
nausea, and haryngolaryngeal pain. Zileuton is contraindicated in patients difficulty breathing,
with active liver disease or transaminase elevations; liver function tests
wheezing, chest
should be monitored. Pregnancy category: C.
tightness, and in
some cases,
Dosing: Two 600mg tablets (1,200mg) twice daily, within one hour after
breathing may
meals.
become so difficult
that a flare-up may
How Supplied: 600mg tabs in bottles of 120 requiring room temperature
become lifestorage.
threatening.
This is a new low dose combination of ethinyl estradiol and levonorgestrel. Oral contraceptives $55.00 per
The product is designed to be taken daily with no placebo phase and
are the leading
month
eliminates the menstrual cycle. Seasonale and Seasonique contain
method of
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
mg/ethinyl estradiol
0.02 mg)
Wyeth
Oral
Approved: 5/22/07
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
levonorgestrel 0.15 mg / ethinyl estradiol 0.03 mg and the regimen results contraception used
in 4 menstrual cycles per year.
among women
ages 15 to 44
Efficacy: The efficacy was evaluated in a multicenter study, involving
years old. 19% of
2,134 women who took one pill daily for 12 months with no pill-free
women in this age
interval. Efficacy was assessed by the number of pregnancies. Only 921 bracket use oral
women completed the trial. Nineteen women (all < 35 years of age)
contraceptive,
became pregnant. The on-treatment Pearl Index was 1.6 (95%CI: 0.96;
equating to 11.6
2.49). The incidence of bleeding was 93.9% at pill pack 1 but reduced to million women.
21% by pill pack 13. The incidence of spotting decreased from 26.7%
during pill pack 6 to 20.2% with pill pack 13.
Safety: Unscheduled bleeding or spotting occurs most often during the
first seven pill packs of Lybrel use. In clinical trials, 60% of women had
bleeding and/or spotting during the 6th pill pack of use. Bleeding and/or
spotting decreased to 48% during pill pack 9, and to 41% during pill pack
13. Pregnancy Category: X.
Dosing: One tablet daily.
How Supplied: Tablets are in a case containing 28 tablets requiring room
temperature storage.
Locoid Lotion
(Hydrocortisone
butyrate, 0.1%)
For the topical
This is a lotion formulation for hydrocortisone butyrate which was
treatment of mild previously available as a cream, ointment and solution. Many forms are
to moderate
available as a generic. There is no generic lotion formulation.
atopic dermatitis
in patients 3
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Atopic dermatitis
(AD), commonly
referred to as
eczema, is a
chronic skin
Not
available
103 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Ferndale
Pharmaceutical
Indication
months of age
and older.
Therapeutic Considerations
Topical
Efficacy and Safety:
The efficacy and safety are equivalent to the efficacy and safety
established for the alternative formulations. The safety of use behond 4
weeks has not been established.
Approved: 5/18/07
Dosing: Apply 2 times a day to affected area.
How Supplied: 2 oz bottle. Store at room temperature.
Seroquel® XR
(quetiapine
extended-release)
AstraZeneca
Oral
Approved: May 18,
2007
Affected Population
Costs
(AWP)
disorder
categorized by
scaly and itching
rashes. People
with eczema often
have a family
history of allergic
conditions such as
asthma or eczema.
For the treatment This is a once daily formulation of quetiapine.
of schizophrenia.
Efficacy:
Efficacy was based on a placebo-controlled study of inpatients and
outpatients (n=573) experiencing an acute exacerbation of symptoms of
schizophrenia with efficacy assessed using the Positive and Negative
Syndrome Scale (PANSS) ratings scale. After 6 weeks (on day 42),
patients recorded a significant improvement in PANSS total scores from
baseline for doses of 400, 600, and 800 mg/day, compared with placebo.
Schizophrenia
$8.35 affects 1% of the
$12.40 per
population. It is a tablet
chronic disorder
that begins in early
adulthood and is
characterized by
delusional beliefs,
auditory
hallucinations, and
A second randomized, double-blind placebo controlled study (Study 004) disorganized
examined time to first psychiatric relapse in 197 patients with clinically
thought patterns.
stable schizophrenia treated with either quetiapine sustained release
The US annual
formulation (mean dose 669 mg/day) or placebo. Patients treated with the cost of loss of
sustained release formulation experienced a significantly reduced risk of
productivity
relapse (risk reduction of 87%, p<0.0001), and a significantly longer time to combined with the
relapse, vs placebo. Differences in relapse rate between active treatment burden of medical
and placebo were large enough to require the study to be stopped early. In care from
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Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
the sustained release group, the estimated risk of relapse after 6 months schizophrenia is
was 14.3% vs 68.2% in the placebo group (p<0.0001). Hospitalization due estimated to be
to worsening of schizophrenia was required by 8.3% of patients on
$32.5 billion.
placebo, but was not needed for any patients taking the sustained release
quetiapine.
Safety:
The most commonly observed adverse reactions (incidence of 5% or
greater) and observed at a rate at least twice that of placebo were dry
mouth (12%), somnolence (12%), dizziness (10%), and dyspepsia (5%).
Pregnancy category: C.
Dosing:
Administered once daily without food, preferably in the evening. The
recommended initial dose is 300 mg. The effective dose range for
SEROQUEL XR is 400 – 800 mg per day depending on the response and
tolerance of the individual patient.
How Supplied:
200mg, 300mg, and 400mg tablets in bottles of 60 and 500 tablets
requiring room temperature storage.
Supprelin®-LA
(histrelin)
Valera/Indevus
For the treatment Injectable histrelin, a GnRH analog, has been available for the treatment of
of central
CPP for 14 years. Roberts Pharmaceuticals began marketing a once-daily
precocious
subcutaneous injection form of Supprelin in 1992.
puberty (CPP)
Efficacy:
Efficacy was based on an open-label, multi-center study of 36 patients
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Precocious puberty $17,500
can be divided into
2 categories:
gonadotropindependent (early
105 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
SC Implant - 12
months
New formulation
Approved: 5/3/07
Indication
Therapeutic Considerations
between ages 4-11 years. Primary endpoints were hormonal suppression
below pubertal levels and continued suppression upon challenge with
gonadotropin-releasing hormone. Sixteen patients had prior treatment with
histrelin, while 20 patients were treatment naive.
Affected Population
activation of the
hypothalamicpituitary-gonadal
(HPG) axis) and
gonadotropinindependent.
Safety: The most common adverse reaction is implant site reaction
(51.1%), including complications related to the insertion or removal of the In the US the
implant. Adverse events related to suppression of endogenous sex steroid incidence of
secretion may occur. Pregnancy category: X.
precocious puberty
is estimated to be
Dosage: One implant every 12 months.
1 per 5000-10,000
individuals.
How supplied: Available as a 50 mg histrelin SubQ implant which delivers Gonadotropin~65 mcg histrelin / day over 12 months. The implant requires refrigeration independent is
prior to insertion.
about 1/5 as
common as
gonadotropindependent.
Lantus SoloStar®
For once-daily
Insulin glargine is a recombinant human insulin analog with a potency
Diabetes is a
subcutaneous
approximately the same as human insulin. It exhibits a relatively constant chronic,
(Insulin glargine)
administration for glucose-lowering profile over 24 hours that permits once-daily dosing. The widespread
the treatment of SoloStar prefilled system is a disposable device.
condition in which
Aventis
adult and
the body does not
pediatric patients Efficacy:
produce or
SC Injection;
with type 1
The efficacy of insulin glargine given once-daily at bedtime was compared properly use insulin
Prefilled, disposable diabetes mellitus to that of once-daily and twice-daily NPH human insulin in open-label,
- the hormone
insulin syringe
or adult patients randomized, active-control, parallel studies of 2327 adult patients and 349 needed to convert
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Costs
(AWP)
Vial: $88.16;
Opticlik:
$36.99;
SoloStar:
$39.99
106 of 120
New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Approved: 4/30/07
Indication
with type 2
diabetes mellitus
who require
basal (longacting) insulin for
the control of
hyperglycemia.
Therapeutic Considerations
Affected Population
Costs
(AWP)
pediatric patients with type 1 diabetes mellitus and 1563 adult patients with glucose (sugar)
type 2 diabetes mellitus. Reduction in hemoglobin A1c (HbA1c) with insulin into energy. More
glargine was similar to that with NPH human insulin.
than 230 million
people worldwide
Three studies were conducted in type 1adult diabetics. In one 28 week
are living with the
study, the adjusted mean change in HbA1c from baseline with insulin
disease. This
glargine vs. NPH was +0.21 and +0.10 respectively (difference of +0.11;
number is
95%CI (-0.03; +0.24). In a second 28 week study the change with insulin expected to rise to
glargine was -0.16 vs. -0.21 with NPH (difference of +0.05; 95%CI (-0.08; a staggering 350
+0.19). Finally in a 16 week trial, the change from baseline in HbA1c was - million within 20
0.07 vs. -0.08 with NPH (difference of +0.01; 95%CI (-0.11; +0.13).
years. It is
estimated more
One 28 week trial was conducted in 349 type 1 pediatric patients. The
than 20 million
adjusted mean change in HbA1c from baseoine with insulin glargine was Americans have
+0.28 vs. +0.27 with NPH (difference of +0.01; 95%CI (-0.24; +0.26).
diabetes, including
an estimated 6.2
Finally 2 trials were conducted in adult type 2 diabetics. The the first tiral, million who remain
570 patients were randomized to insulin glargine vs NPH insulin in
undiagnosed. At
combination with oral hypoglycemic agents. After 52 weeks the mean
the same time,
change in HbA1c from baseline with insulin glargine was -0.46 vs -0.38
approximately half
with NPH (difference of -0.08; 95%CI (-0.28; +0.12). In t a second 28
of those diagnosed
week trial in 518 patients treated with regular insulin, combined therapy
are not achieving
with insulin glargine resulted in a change in HbA1c from baseoine of -0.41 the general blood
vs. -0.59 with NPH (difference of +0.17; 95%CI (-0.00; +0.35).
sugar control
standard of A1C
The overall rates of hypoglycemia did not differ between patients with
<7%
diabetes treated to insulin glargine compared with NPH human insulin.
recommended by
the American
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Safety:
Diabetes
Insulin glargine may not be mixed with any other insulin or solution.
Association (ADA).
Adverse events associated with insulin glargine were: allergic reactions;
injection site reaction, lipodystrophy, pruritus, rash; and hypoglycemia.
Patients being switched from twice daily NPH insulin to once-daily insulin
glargine should have their initial insulin glargine dose reduced by 20%
from the previous total daily NPH dose to reduce the risk of hypoglycemia.
The prolonged effect of insulin glargine may delay recovery from
hypoglycemia. In a clinical study, symptoms of hypoglycemia or
counterregulatory hormone responses were similar after intravenous
insulin glargine and regular human insulin both in healthy subjects and
patients with type 1 diabetes. In clinical studies in adult patients, there
was a higher incidence of treatment-emergent injection site pain in insulin
glargine-treated patients (2.7%) compared to NPH (0.7%). The reports of
pain at the injection site were usually mild and did not result in
discontinuation of therapy. Pregnancy Category C.
Dosing: Insulin glargine should be administered subcutaneously once a
day at the same time every day.
How Supplied: 100 units/mL in the following package size: 10 mL vial; 3
mL cartridge system for use in OptiClik® ); and 3 mL SoloStar® disposable
device. All packages are stable until the manufacturer's expiration date if
refrigerated. Packages are stable at room temperature for 28 days.
Opened containers are stable for 28 days at room temperature or under
refrigeration. The OptiClik pen and the SoloStar systems SHOULD NOT
be refrigerated after opening for use.
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New Drug Approvals – 2007
Drug
Manufacturer
Route
Approval date
Veramyst™
Indication
For treatment of
symptoms of
(fluticasone furoate) seasonal (SAR)
and perennial
Nasal spray
allergic rhinitis
(PAR) in adults
GlaxoSmithKline
and children
≥2 years
Approved: 4/27/07
Therapeutic Considerations
Fluticasone furoate (Veramyst) is a new nasal spray formulation. This
agent will compete with fluticasone propionate (Flonase, and generics).
These agents are administered once daily for allergic rhinitis.
Efficacy:
Efficacy was based on 5 trials involving 1,829 patients ≥12 years of age
with seasonal (SAR) or year-round allergies (PAR). Compared to placebo,
the agent improved overall nasal symptoms and ocular symptoms,
including itchy eyes in patients with SAR. Effectiveness was sustained for
24 hours. In studies involving 1,112 children with SAR or PAR, 2 - 11
years of age, once-daily fluticasone effectively treated overall nasal
symptoms, which included congestion, sneezing, itchy nose and runny
nose. Improvement in eye symptoms was not shown in patients ≥12 years
with PAR or in patients two to 11 years of age with SAR or PAR.
Safety:
Common adverse events included headache, nose bleed and nasal sores.
Nose bleed occurred more frequently in the fluticasone group (20%) vs.
placebo (8%). Fever was more frequent in children aged two to 11 vs.
placebo. Co-administration with CYP3A4 inhibitors is cautioned, product
labeling contains details of drug combinations to avoid. Labeling contains
warnings regarding Candida albicans infection, nasal septal perforation
and impaired healing. Pregnancy category C.
Dosing: ≥12 years: 110 mcg (2 sprays per nostril) once daily. Children 211 years: 55 mcg (1 spray per nostril) once daily.
Affected Population
Costs
(AWP)
Allergic rhinitis is
$94.74 per
an inflammatory
Rx
reaction of the
nasal passages to
allergens, such as
animal dander and
pollens. Nasal
allergies affect up
to 40 million in the
US, including 10%
to 30% of adults
and up to 40% of
children. The
symptoms include
nasal congestion,
sneezing and itchy
nose. Seasonal
allergic rhinitis,
occurs during
certain seasons
and lasts a few
weeks to a few
months. Perennial
allergic rhinitis,
triggered by animal
dander and mold,
occurs year-round.
How Supplied: In a device as a scent-free, suspension. Provides 120
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Drug
Manufacturer
Route
Approval date
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
sprays delivering 27.5 mcg in 50 microliters. Store between 15°-30°C
(59°-86°F).
Tovalt™ ODT
zolpidem ODT
For the short
This is a new ODT formulation of zolpidem. Zolpidem is the active
term treatment of ingredient in the brand product Ambien (available as a generic). Tovalt
insomnia
ODT is bioequivalent to Ambien.
Biovail
Oral
NDA approved:
4/25/07
Enjuvia™
Treatment of
moderate to
(synthetic conjugated severe vaginal
estrogens, B)
dryness and pain
with intercourse,
Barr
symptoms of
vulvar and
Oral
vaginal atrophy,
associated with
New 0.9 mg tablet
menopause.
and new indication
Insomnia is a
Not
prevalent condition available
in the US, with
~40% of adults
Efficacy and Safety: The efficacy and safety profiles of zolpidem are well
reporting trouble
established. Pregnancy category: C.
sleeping, according
to the National
Dosing: 10mg immediately prior to bed without food with or without water. Sleep Foundation's
5mg in elderly or patients with reduced hepatic function.
(NSF) Sleep in
America Poll ‘02.
How Supplied: 5mg and 10mg tablets in packs of 28 requiring room
temperature storage.
Enjuvia is the first oral estrogen approved to treat moderate-to-severe
vaginal dryness/pain, symptoms of vulvar/vaginal atrophy, associated with
menopause. It is recommended that topical vaginal products be
considered when treating vaginal dryness.
Decreased
$1.33 per
estrogen levels in tablet all
menopause leads doses
to vaginal/vulvar
dryness and
Efficacy: Efficacy was established in a randomized, double-blind, placebo- thinning, which
controlled, multi-center trial in 248 postmenopausal women between 32 to may result in
81 years who had moderate to severe symptoms of vulvar/vaginal atrophy. inflammation of the
All patients were assessed for improvement in the mean change from
vaginal mucosa
baseline to Week 12 for three co-primary variables: most bothersome
(atrophic vaginitis).
symptom of vulvar/vaginal atrophy; % of vaginal superficial cells and % of Atrophy may cause
vaginal parabasal cells; and vaginal pH. Comparing week 12 to baseline, irritation,
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Route
Approval date
Indication
Approved: 4/23/07
Therapeutic Considerations
therapy with Enjuvia 3mg vs. placebo resulted in a significant improvement
in vaginal dryness, a mean increase in superficial cells of 17.1% vs 2.0%,
a significant mean reduction in parabasal cells by 41.7% vs 6.8%, and a
mean reduction in pH by 1.69 vs 0.45, respectively.
Affected Population
Costs
(AWP)
dyspareunia, and
dysuria and may
increase vaginal
pH.
Safety: The safety profile of oral estrogen products is well established.
Dosing: Patients should be started at the lowest dose of 0.3 mg daily.
Subsequent dose adjustment may be made based on patient response.
How Supplied: Supplied as 0.3, 0.45, 0.625, 0.9 and 1.25mg tablets in
bottles of 100 requiring room temperature storage.
Valtropin®
(somatropin)
LG Life sciences
Subcutaneous
Injection
Approved: 4/19/07
For the treatment
of children with
growth failure
due to
inadequate
secretion of
endogenous
growth hormone,
for the treatment
of short stature in
children with
Turner
Syndrome, and
as replacement
therapy in adults
Valtropin® (somatropin) is produced by recombinant DNA technology in
yeast cells (Saccharomyces cerevisiae). Humatrope and Omnitrope are
synthesized in a strain of Escherichia coli that has been modified by the
addition of the gene for human growth hormone. Valtropin is a biosimilar
version of Eli Lilly’s Humatrope. Valtropin will compete with Omnitrope and
Humatrope.
Efficacy:
Pediatric Growth Hormone Deficiency (GHD)
Efficacy in treatment naïve pediatric patients with GHD was evaluated in a
single, 12 month, MC, R, DB, study comparing Valtropin (n=99) to
somatropin control (n=50). Valtropin was non-inferior with the comparator
(height velocity = 11.21 cm/year vs. 11.0 cm/year respectively). Bone
maturation was not accelerated and mean serum insulin-like growth factor
1 (IGF-1) levels were increased similarly in both groups.
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Turner syndrome Not
is a rare genetic
available
disorder that
affects 1 in 2,000
to 5,000 live
female births or
0.02% or 54,400
people in US.
Turner syndrome
manifests itself
differently in each
female affected.
Common
symptoms include,
short stature,
111 of 120
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Approval date
Indication
Therapeutic Considerations
with growth
hormone
deficiency (GHD)
of either
childhood or
adult onset.
Children with Turner Syndrome
Two uncontrolled trials of 12 month duration evaluated efficacy in girls with
Turners Syndrome (N=90). Treatment with Valtropin consisted of the
following two doses; 0.053 mg/kg/day SQ or 0.056 mg/kg/day for 6 days a
week SQ. The mean change in height velocity ranged from 3.49 cm/year
to 5.98 cm/year with Valtropin.
swelling of the
hands and feet,
sterility, absence
of a menstrual
period, and
hearing loss.
Adults:
Efficacy in adult patients was evaluated in a 6 month, MC, R, DB, PC trial
in either adult onset or childhood onset GHD (n=92). Dosing was initiated
at 0.33 mg/kg/day for 6 days a week for 1 month; after this month the dose
was adjusted in response to serum IGF-1 levels or adverse effects to a
max of 0.66 mg/kg/day for 6 days a week. Change in fat mass and lean
body mass were the efficacy variables evaluated. After 3 months, the
change in fat mass (adjusted mean) was -1.35kg. Lean body mass
increased significantly with Valtropin treatment. The table below shows
the change in fat mass and increase in lean body mass after 3 and 6
months.
Fat Mass
Lean Body Mass
(mean ± SD)
Mean Change from Baseline
Baseline
21.9 ± 6.0 kg
Month 3
20.2 ± 6.3 kg* 1.0 kg*
Month 6
19.6 ± 5.7 kg* 2.1 kg*
*Statistically significant within-group change from baseline (p<0.05).
GH deficiency also
occurs from other
pituitary-related
disease or from a
deficiency in
childhood. GHD is
not uncommon in
children. The
worldwide
incidence has been
estimated to be at
least 1 in 10,000
live births and
some individual
countries have
reported an
incidence as high
as 1 in 4,000 live
births.
GH deficiency in
adults results from
Safety:
The adverse events seen most frequently (≥5.0%) were: headache,
pyrexia, cough, respiratory tract infection, diarrhea, edema, glucose
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Affected Population
Costs
(AWP)
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Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
intolerance, vomiting and pharyngitis. The incidence was similar to
somatropin. Few patients tested anti-rhGH antibody positive and anti yeast
antibody positive. Exacerbation of existing central hypothyroidism was
reported. Pregnancy category B.
Actonel®
(risedronate)
Oral
Proctor and Gamble
Approved:
4/16/07
a pituitary or peripituitary tumor or
as a direct result of
the surgery or
radiation used to
Dosing: Dosing varies based on age and indication. Somatropin is usually treat the tumor.
dosed 6 days per week and is given SQ. Specific dosing can be found in The prevalence
product labeling.
rate of adults with
GH is ~2 in 10,000
How Supplied: Package with a 5mg vial of somatropin and a pre-filled
of the adult
syringe containing 1.5mL diluent. Before reconstitution, the package
population, with
requires stored under refrigeration (2°C-8°C/36°F-46°F). May be stored at adult-onset GH
or below 25°C (77°F) for up to three months after dispensing.
accounting for ~1
in 10,000.
For prevention
This is a new strength of Actonel in a 75mg tablet that is dosed monthly.
In the U.S. today, $52.16 per
and treatment of The drug is currently available in a 5mg tablet dosed daily or a 35mg tablet 8 million women
each 75mg
postmenopausal dosed weekly. Actonel will compete with other oral bisphosphonates
tablet
are estimated to
osteoporosis
Boniva and Fosamax.
already have
Efficacy: Efficacy was studied in an active-controlled, double-blind trial of
1,229 postmenopausal women with osteoporosis aged ≥50 years with
lumbar spine bone mineral density (LS BMD) T-score ≤ -2.5 or a LS BMD
T-score ≤ -2.0 and at least one vertebral fracture. Increases in LS BMD,
total hip, and hip trochanter with Actonel 75 mg, taken on two consecutive
days a month, were similar to those in patients treated with 5 mg daily at 6
and 12 months.
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osteoporosis, and
almost 27 million
more are
estimated to have
low bone mass,
placing them at
increased risk for
fracture.
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Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Safety: In a clinical trial comparing Actonel 75 mg two consecutive
days/month vs 5 mg daily for 1 year, the overall safety and tolerability of
the two dosing regimens were similar. The most commonly reported
adverse events regardless of causality were arthralgia (Actonel 75 mg
10.4% vs Actonel 5 mg 9.5%), dyspepsia (9.1% vs 7.3%), and back pain
(8.8% vs 10.8%). Pregnancy category C.
Dosing: 75 mg tablet taken on 2 consecutive days each month.
How Supplied: A dose-pack containing 2 tablets requiring room
temperature storage.
Risperdal® Consta® For the treatment The new dose of Risperdal Consta is the lowest formulation of the longof schizophrenia. acting injection. Risperdal Consta is also available in 25 mg, 37.5 mg and
risperidone depot
50 mg dose units. The FDA approval of the 12.5 mg dose was based on
pharmacokinetic data in schizophrenia patients that demonstrated an
J&J
expected profile for the lower dosage strength.
Injection- IM
New 12.5 mg dosage
form
Approved: 4/13/07
Initial approval in
2003
Schizophrenia
$149.13 per
affects 1% of the
12.5mg
population. It is a dose pack
chronic disorder
that begins in early
adulthood and is
Efficacy and Safety:
characterized by
Efficacy and safety were based on that established with previous doses of delusional beliefs,
Risperdal Consta. The efficacy and safety of the 12.5 mg dose has not
auditory
been investigated in clinical trials. This agent carries a black box warning hallucinations, and
regarding the increased mortality in elderly patients with dementia-rrelated disorganized
psychosis.
thought patterns.
The US annual
Dosing:
cost of loss of
It is recommended to establish tolerability with oral risperidone prior to
productivity
initiating treatment with Risperdal Consta. Risperdal Consta should be
combined with the
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administered every 2 weeks by deep IM gluteal injection. Each injection
should be administered by a health care professional. The recommended
dose is 25 mg IM every 2 weeks. The maximum dose should not exceed
50 mg every 2 weeks. A lower initial dose of 12.5 mg may be appropriate
when clinical factors warrant dose adjustment, such as in patients with
hepatic or renal impairment, for certain drug interactions. Oral risperidone
should be given with the first injection of Risperdal Consta and continued
for 3 weeks (and then discontinued) to ensure that adequate therapeutic
plasma concentrations are maintained.
Affected Population
Costs
(AWP)
burden of medical
care from
schizophrenia is
estimated to be
$32.5 billion.
How Supplied:
Available in dosage strengths of 12.5, 25, 37.5, or 50 mg risperidone. It is
provided as a dose pack, consisting of a vial and a pre-filled syringe
containing 2 mL of diluent for intramuscular injection.
Janumet®
(metformin/
sitagliptin)
Merck
Oral
Approved: 3/30/07
Adjunct to diet
and exercise to
improve glucose
control in adult
patients with type
2 diabetes who
are not
adequately
controlled on
metformin or
sitagliptin alone,
or in patients
already being
Janumet is an oral medicine combining Januvia, a DPP-4 inhibitor,
(sitagliptin) with metformin. The mechanism of action of DPP-4 inhibitors is
distinct from that of metformin and all other glucose-lowering agents. DPP4 inhibitors work by enhancing the body's own ability to lower blood
glucose when it is elevated.
Efficacy:
Efficacy was based on a 24-week, randomized, double-blind, placebocontrolled study (N=701) in patients with elevated HbA1c (mean baseline
8%) inadequately controlled on metformin. Patients taking
sitagliptin/metformin (n=453) experienced mean reductions in HbA1c of
0.7% beyond that achieved by patients on metformin alone (n=224)
(p<0.001). 47% (213/453) of patients on the combination reached the
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Type 2 diabetes is $4.86 per
a condition in
day (BID
which the body has dosing)
elevated blood
sugar or glucose.
Nearly 21 million
people in the US
(7% of the
population) have
diabetes, with type
2 accounting for
90-95% of cases.
Approximately half
115 of 120
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Route
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Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
treated with a
HbA1c goal of <7% vs. metformin alone (41/224; 18%) (p<0.001). In a 24sitagliptin/metfor week study, mean body weight decreased 1.5 lb (n=399) in patients taking
min combination sitigliptin/metformin vs. metformin alone (1.3 lb; n=169). In a 24-week,
placebo-controlled study of patients with inadequate glycemic control on
metformin, the combination significantly reduced PPG and FPG levels vs.
metformin alone:
 Patients (n=387) with Baseline 2-hour PPG mean = 275 mg/dL; the
mean decrease in PPG was 51mg/dl (p<0.001)
 Patients (n=454) with Baseline FPG mean = 170 mg/dL; the mean
decrease in FPG was 25 mg/dL (p<0.001).
of people
diagnosed with
type 2 diabetes
have not achieved
adequate control of
their blood sugar
levels. Patients
with diabetes can
develop heart
disease, kidney
disease, blindness,
Safety:
vascular or
Adverse effects of combination treatment with sitagliptin plus metformin
neurological
compared to metformin alone included diarrhea (9% vs. 10%,
problems that can
respectively), nausea (6% vs. 8%, respectively), abdominal pain/discomfort lead to amputation
(3% vs. 5%, respectively) and vomiting (3% vs. 1%, respectively).
and can suffer
Pregnancy category: B. There is a boxed warning for lactic acidosis
increased rates of
(similar to labeling for metformin).
mortality
Dosing: Starting dose: 50 mg twice daily of sitagliptin plus the dose of
metformin already being taken. For patients not adequately controlled on
sitagliptin alone and not on prior metformin, the usual stating dose is 50
mg sitagliptin/500 mg metformin twice daily. The total daily dose should
not exceed 100 mg sitagliptin and 2,000 mg metformin.
How Supplied: As sitagliptin/metformin 50 mg/500 mg and 50 mg/1000 mg
tablets in bottles of 60, 180 and 1,000 and blister packages of 50 tablets
requiring room temperature storage.
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Approval date
Amrix®
(cyclobenzaprine
extended release
capsules)
ECR
Pharmaceuticals
Oral
Approved;
Feb 1, 2007
Indication
Therapeutic Considerations
As an adjunct to
rest and physical
therapy for relief
of muscle spasm
associated with
acute, painful
musculoskeletal
conditions.
Cyclobenzaprine is a skeletal muscle relaxant which relieves muscle
spasm of local origin without interfering with muscle function. Amrix is a
new extended-release formulation. Cyclobenzaprine is the same chemical
in the branded product, Flexeril. Immediate release cyclobenzaprine is
available as a generic.
Affected Population
Costs
(AWP)
Muscle spasms
~ $9.30 per
and are
tablet, all
spontaneous, often doses
painful muscle
contractions.
Skeletal muscle
Efficacy: Efficacy was assessed in two double-blind, parallel-group,
spasms can result
placebo-controlled studies of Amrix 15mg and 30mg taken once daily in
from a variety of
patients with muscle spasms associated with acute painful
causes and
musculoskeletal conditions. There were significant differences in the
medical conditions.
primary efficacy analysis, (patient rating of helpfulness), between the Amrix Skeletal muscle
15mg group and the placebo group at Days 4 and 14 in one study and
spasms are
between the Amrix 30mg group and the placebo group at Day 4 in the
commonly
second study. In addition, one of the studies demonstrated significant
diagnosed and the
differences between the Amrix 30mg group and the placebo group in terms incidence is
of patient-rated relief from muscle spasm and subject-rated restriction of
unknown.
movement at Day 4 and Day 8, and in patient-rated global impression of
change at Day 4, 8, and 14.
Safety: The most common adverse events were: somnolence 100%, dry
mouth 58%, headache 17%, dizziness 19%, vision blurred 3%, nausea
8%, dysgeusia 6%, palpitations 6%, and tremor 6%. Pregnancy category:
B.
Dosing: 15mg once daily. Some patients may require up to 30 mg/day.
How Supplied: Extended-release capsules in 15 and 30 mg strengths,
packaged in bottles of 60 capsules requiring room temperature storage.
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Approval date
Flector®
(diclofenac
epolamine, 1.3%)
INST Biochem
Topical patch
Approved: 1/31/07
Indication
Therapeutic Considerations
Affected Population
Costs
(AWP)
Diclofenac 1.3% patch is a non-steroidal anti-inflammatory (NSAID) drug.
For the topical
Currently, a 1% gel (Voltaren) is marketed for osteoarthritis and a 3%
treatment of pain
topical gel formulation is marketed as Solaraze which is indicated for
due to minor
treatment of actinic keratosis.
sprains or injury.
Muscle sprains and $5.62 per
strains are
patch
common. For
ankle injuries
alone, it is
Efficacy:
estimated that ~1
Efficacy was demonstrated in 2 of 4 studies of patients with minor sprains million occur each
and contusions. Patients were randomly assigned to diclofenac patch or a year, and 85% of
placebo patch. In the first study, patients with ankle sprains were treated
them are sprains.
once daily for a week. In the 2nd study, patients with sprains were treated
twice daily for up to2 weeks. Patients treated with diclofenac patch
experienced a greater reduction in pain as compared to patients
randomized to placebo patch.
Safety:
Diclofenac topical carries a black box warning similar to all NSAID agents
with regard to increased risk (including possible death) of serious
cardiovascular thrombotic events, and serious gastrointestinal events
including bleeding, ulceration, and perforation. Dicolfenac is
contraindicated for pain with coronary artery bypass graft surgery and for
use in patients with a history of asthma or hypersensitivity to aspirin or
NSAIDS.
Warnings: Package labeling contains warnings similar to all NSAIDs
regarding potential increased liver enzymes, renal necrosis, hypertension,
fluid retention, anaphylactoid reactions, and skin events. The most
common events from topical use (incidence >2%) were application site
reactions, including dermatitis. Pregnancy Category: C.
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Affected Population
Costs
(AWP)
Dosing: One patch twice a day.
How Supplied: in resealable envelopes, each containing 5 patches
with one or two envelopes per box. Each patch contains 180 mg of
diclofenac epolamine in an aqueous base requiring room temperature
storage.
Olux-E™
(clobetasol
propionate foam
0.05%)
Stiefel
Topical
Approved:
1/12/07
For the treatment
of inflammatory
and pruritic manifestations of
corticosteroid
responsive
dermatoses, also
known as
psoriasis and
eczema, in
patients 12 years
of age or older
Olux-E foam 0.05% is a super-high potency topical steroid. The vehicle
for this formulation is VersaFoam-EF™ Emulsion Formulation, which
provides the hydrating and emollient benefits of ointments and emollientcream vehicles. Olux-E will compete with other clobetasol products
(Olux™, Temovate®, etc).
According to the
National Institute of
Health (NIH),
between 5.8 and
7.5 million in the
U.S. have
Efficacy: Efficacy was studied in 2 randomized, double-blind, vehicle
psoriasis. Psoriasis
controlled trials. In patients with atopic dermatitis, Olux-E Foam (n=251) is caused by
was compared to Vehicle (n=126) used twice daily for 2 weeks. Success excess
was higher with Olux-E (52%) vs Vehicle (14%). In patients with plaque- inflammation and
type psoriasis, Olux-E (n=253) and vehicle Foam (n=123) used twice
results in red,
daily for two weeks were compared. At the end of treatment, success was thickened, scalehigher with Olux-E (16%) vs. Vehicle (4%).
like areas on the
skin. According to
Safety: Clobetasol foam has been shown to suppress the HPA axis.
the National
Clobetasol should not be used on the face, groin, axillae, or intertriginous Institute of Arthritis
areas. The most common adverse events are application site atrophy
and
(1.9%) and site reaction (1.6%). Local adverse events were rated as
Musculoskeletal
mild/moderate and were not affected by age, race or gender. Pregnancy and Skin Diseases
category C.
(NIAMS), more
than 15 million
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50gm =
$142.00;
100gm =
$261.00
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Indication
Therapeutic Considerations
Dosing: Application of a thin layer twice daily. Treatment should be
limited to 2 weeks. Patients should not use > 50 Gm (= 21 capfuls)/
week. Olux-E Foam should not be used with occlusive dressings.
Affected Population
Costs
(AWP)
people in the U.S.
have symptoms of
atopic dermatitis
(eczema).
How Supplied: Available in 50gm and 100gm canisters requiring room
temperature storage.
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120 of 120