FDA Advisory Committee postpones decision on eteplirsen as a treatment for Duchenne Muscular Dystrophy- Sarepta

Sarepta Therapeutics, Inc. announced that the FDA has notified the Company that they are continuing their review and internal discussions related to the pending NDA for eteplirsen and will not be able to complete their work by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016. The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

Comment: The FDA has previously been unconvinced by the modest evidence offered by Sarepta Therapeutics and has advised the company to carry out a larger controlled trial to determine the efficacy of the drug. Applications from PTC Therapeutics snd BioMarin for treatments of Duchenne Muscular Dystrophy have recently been rejected by the FDA.