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News You Can Use… Pete Koval, PharmD Alvin Oung, PharmD Cone Health Family Medicine March 2015 News You Can Use… This news cycles automatically & IS INTENDED to provide incentive to arriving early! Thanks for coming early! New Drug Approval • Avycaz (ceftazidime + avibactam) received FDA approval for the treatment of complicated intra-abdominal infections, in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis • This is the 2nd cephalosporin/β-lactamase inhibitor combination approved for use in patients who have limited or no alternative treatments in cIAIs and/or cUTIs • Zerbaxa (ceftolazane + tazobactam) was approved in December 2014 02/25/2015 FDA News and Events New Drug Approval • Savaysa (edoxaban) received FDA approval for the treatment of DVT/PE and prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation • Similar MOA to rivaroxaban and apixaban • Shown to have similar efficacy and reduced bleeding risk compared to warfarin but with various restrictions, ex: contraindicated in CrCl > 95 ml/min 01/08/2015 CenterWatch New Drug Approval • Toujeo (insulin glargine [rDNA origin] injection, 300 U/ml]), a once-daily long-acting basal insulin, received FDA approval to treat Type 1 and Type 2 diabetes • Same active ingredient as Lantus, but at three times the concentration and suggested to have a design to release insulin more gradually • Lower rates of hypoglycemia were seen in clinical trials by not mentioned in the FDAapproved label 02/25/2015 FDA News and Events In the pipeline • Novo Nordisk announced that it has successfully completed its Phase 2 trial for once-daily oral semaglutide vs onceweekly subcutaneously administered semaglutide (in Phase 3) • This would be the first oral GLP-1 receptor agonist for the treatment of Type 2 diabetes 02/20/2015 ClinicalTrials.gov New Drug Approval • Farydak (panobinostat) received FDA approval for the treatment of patients with multiple myeloma • This is the first HDAC (histone deacetylase) inhibitor approved to treat multiple myeloma • Intended to be used in combination with bortezomib and dexamethasone 02/23/2015 FDA News and Events New Drug Approval • Lucentis (ranbizumab) 0.3 mg injection received expanded approval from the FDA to treat diabetic retinopathy in patients with diabetic macular edema • The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions • Lucentis is also approved to treat wet age- related macular degeneration 02/06/2015 FDA News and Events Hepatitis C Medication Updates • Daclatasvir, with sofosbuvir, shows 97% SVR12 rates in genotypes 1-4 with co-infected HIV patients in Phase 2 Trials • Gilead announces 96% SVR12 Rates from Phase 3 Study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for Hepatitis C genotypes 1 or 4 among patients co-infected with HIV on ART • Plans to file supplemental New Drug Application 02/26/2015 Hepatitis C New Drug Research New Drug Approval • Cosentyx (secukinumab) received approval from the FDA for the treatment of moderate to severe plaque psoriasis • This is the first approved human monoclonal antibody that selectively inhibits IL-17A 01/21/2015 FDA News and Events