The US FDA has posted details, including company and FDA Briefing Materials, for the Monday, April 25, 2016 Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting. The Committee will discuss new drug application (NDA) 206488 for eteplirsen (injection for intravenous infusion), by Sarepta Therapeutics, Inc. (Sarepta), for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.

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