POSTPONED: Peripheral and Central Nervous Systems Drugs Advisory Committee

The U.S. FDA has postponed the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee meeting for January 22, 2016 for inclement weather. The Committee was scheduled to 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. Tarius monitored the Federal Register for FDA's announcement of a new date for the meeting, and the new date for the meeting is April 25, 2016.