Despite Negative FDA Panel, Needham & Company Sees Approval of Sarepta's (SRPT) Eteplirsen as Early as Next Year

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Go back to Despite Negative FDA Panel, Needham & Company Sees Approval of Sarepta's (SRPT) Eteplirsen as Early as Next Year

Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy

April 25, 2016 10:58 PM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-based therapeutics, today announced that the U.S. Food and Drug Administrations (FDA) Peripheral and Central Nervous System Advisory Committee (PCNSC) met to review the new drug application (NDA) for eteplirsen as a treatment for Duchenne muscular dystrophy amenable to exon 51 skipping. The advisory committee voted 6-7 against the finding of substantial evidence from adequate and well controlled studies that show that eteplirsen induces production of dystrophin to a level that is reasonably likely to predict clinical benefit (FDA Question #2). The... More