AdCom votes 8-6 in support of accelerated approval of Sarepta's SRP-9001

Friday turned out to be a positive day for Sarepta Therapeutics (Nasdaq: SRPT), with a narrow, but positive, regulatory advisory committee vote.

Despite what appeared to be somewhat negative briefing documents from agency staff ahead of the meeting, the US Food and Drug Administration’s (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) on Friday voted 8 to 6 in support of accelerated approval of Sarepta’s SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene.

The FDA is slated to make a decision on accelerated approval of the Biologics License Application (BLA) for the drug by May 29. The agency typically follows the advice of its expert advisers but is not obligated to do so.