The U.S. FDA has scheduled a Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee meeting for January 22, 2016. The Committee will discuss new drug application (NDA) 206488 for eteplirsen injection for intravenous infusion, submitted by Sarepta Therapeutics, Inc., 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.

See the FDA Announcement