Background Analysis: US FDA Advisory Committee to Review Sarepta’s Eteplirsen for Duchenne Muscular Dystrophy – APR 25, 2016 (PCNS)

The US FDA has scheduled a Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) meeting for Monday April 25, 2016 to 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.

Originally, this meeting was scheduled for January 22, 2016, but it was postponed due to inclement weather.

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