Download Tysabri: a few answers

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n A new treatment
option: Tysabri
returns, with controls­
On June 5, the U.S. Food
and Drug Administration
(FDA) released Tysabri
back to market for people with relapsing MS,
despite its risk of causing
PML, a potentially fatal
disease. To minimize
this risk, the drug will be
available only at authorized infusion centers
using a rigorous monitoring program.
Tysabri (natalizumab),
which is given as a
monthly IV infusion,
was withdrawn in 2005
by Biogen Idec and Elan
Pharmaceuticals, Inc.,
after three people among
the 3,000 who had been
taking the drug in clinical trials developed PML
(progressive multifocal
leukoencephalopathy).
Two of them died.
But last March at a
special hearing before an
FDA advisory panel, dozens of people affected by
38
InsideMS
MS testified about
what Tysabri meant
to them. The panel
evaluated data
suggesting that
Tysabri may have
twice the efficacy
rate of other MS
treatments. After reviewing additional safety
studies and a proposed
risk management
plan, the panel
recommended the
drug’s return. That
recommendation
is now formally
accepted. The
approval includes
a mandatory registration
program for patients and
their prescribing physi-
Tysabri: a few answers
Who should take Tysabri?
Tysabri is approved
for people with relapsing forms of MS who
do not have another
condition that weakens the immune system, such as cancer or
lupus.
It is FDA-approved
as a monotherapy. It
cannot be used with
Avonex, Betaseron,
Copaxone, Rebif,
Novantrone, monthly
IV steroids or other
immune modulating
drugs.
How is Tysabri given?
Tysabri is given once
a month by intravenous
infusion, only at an
authorized infusion
center. What is the primary
safety concern regarding
Tysabri?
People taking Tysabri
risk developing PML.
How will safety risks
be managed?
At all infusion centers,
physicians and patients
will be registered in a
mandatory program
called TOUCH. Medical
personnel will receive
www.nationalmssociety.org/InsideMS.asp
cians. The drug also carries a “black box” warning
describing the risks.
“It’s important that people
with relapsing MS now
have a new treatment
option,” said John R.
Richert, MD, vice president
of Research and Clinical
Programs for the Society.
“Because of the risk of
PML,” Dr. Richert continued, “the FDA is recommending that Tysabri be
given only to people who
have had an inadequate
response to, or are unable
to tolerate, the other MS
therapies—Copaxone,
Betaseron, Avonex, Rebif,
or Novantrone. But they
leave it to individual
physicians and patients
to define ‘inadequate
response’ and what it
means to be ‘unable to tolerate’ other therapies, giving physicians and people
with MS leeway to exercise
their best judgment.
“We believe that the
mandatory patient registry
and the post-marketing
observational study will
help clarify the potential
risks and benefits of this
new therapy for people
with MS,” Dr. Richert said.
Biogen and Elan’s postmarketing study will follow at least 5,000 people
prescribed Tysabri for five
years to evaluate the longterm safety. Dr. Richert
urged people considering
any MS treatment to discuss the options with their
health-care professional.
special training in recognizing early signs of PML.
Information about all the
risks and side effects will
be given to each patient.
Before every infusion,
medical staff and patients
will complete a checklist
for signs of PML and other
side effects.
Is Tysabri available
everywhere?
Biogen Idec began supplying Tysabri to infusion
centers in July, and are
continuing to train healthcare professionals and register new centers around
the country. For information about centers, contact
Biogen Idec.
How expensive is Tysabri?
The annual wholesale
cost of Tysabri is $28,400.
There will be additional
charges for infusion
­services.
Will insurance cover the cost?
There may be a lag
time before the drug is
included in private health
plans. Prior authorization
will probably be necessary
for most health plans.
Tysabri is expected to be
covered by Medicare Part
B because it is given at a
medical facility.
People with Medicaid
should check with their
state program. There
may be a delay before
Tysabri is included in the
Medicaid preferred drug
list.
More information is
available three ways:
1. From us at www.
nationalms society.org/
tysabri or call your chapter at 1-800-FIGHT-MS
(1-800-344-4867)
2. From the FDA at
www.fda.gov/cder/drug/
infopage/natalizumab/
default.htm
3. From Biogen Idec
at www.biogenidec.com
or call 1-800-456-2255.
A new option added to our list
August–September 2006
InsideMS
39
n MS research
advances reported
at AAN
The results of more than
200 MS-related clinical
trials and studies were
presented at the American
Academy of Neurology’s
58th Annual Meeting in
San Diego this past April.
Among the highlights:
Earlygoodnewsthatwill
needconfirmation
n A study funded by the
National MS Society’s Initiative on Gender Differences in MS showed that
applying AndroGel (a testosterone gel) to the skin
of 10 men with relapsingremitting MS for one year
improved cognitive function and slowed brain
tissue loss. Dr. Rhonda
Voskuhl and colleagues at
the University of California, Los Angeles, did this
work.
n Dr. Timothy Vollmer of
Barrow Neurological Institute, Phoenix, reported
that 30 people taking a
combination of BHT3009, an immune system
modifier, and Lipitor, a
cholesterol-lowering drug,
did well. The combination appears safe and pro40
InsideMS
vided protection from MS
immune attacks.
n MedlinePlus
Largerstudies,
closertofruition
Started in 1998 by the
National Institutes of
Health (NIH), Medline
Plus (www.medlineplus.
com) is one of the most
visited health-related sites
on the Web, receiving millions of hits every month.
The site provides up-to-date
information for professionals and lay
people on
medical
conditions,
drugs and
supplements,
and other
topics.
This summer, the
NIH broke into print with
NIH MedlinePlus Magazine, a quarterly that offers
authoritative advice on
health, news on medical
research, and stories about
people who are making
medical advances.
NIH MedlinePlus
Magazine is free. Write to:
Friends of the National
Library of Medicine, P.O.
Box 31130, Bethesda, MD
20814, or download it
at www.nlm.nih.gov/
medlineplus/magazine.
html.
n Dr. Paul O’Connor and
team at St. Michael’s Hospital, Toronto, released
results from a phase 2
clinical trial of an oral
MS drug called FTY720,
or Fingolimod. Relapse
rates and inflammation
as detected by MRI were
both significantly reduced
by the drug. A definitive
phase 3 study is underway
in Europe and planned
for North America; go to
www.novartisclinical
trials.com/portals/MS
Clinicaltrials/page.do for
details.
n Dr. Mark Freedman of
the University of Ottawa
presented the BENEFIT
study data. Of 487 people
at high risk of developing
MS, those given Betaseron (interferon beta-1b)
were 50% less likely to
develop definite MS than
those given an inactive
placebo. Participants in
this trial had CIS, or clinically isolated syndrome,
meaning they had each
had a single demyelinating event, but had not
been diagnosed with MS.
launches magazine
www.nationalmssociety.org/InsideMS.asp