Accelerated approval for Sarepta drug?
Woodcock specifically mentioned it’s possible the FDA could place Sarepta Therapeutics Inc (NASDAQ:SRPT)’s Duchenne MD drug in its accelerated approval program. This means the agency would be willing to accept data from a clinical trial using a surrogate marker to suggest a clinical benefit. Sarepta also released results of a small study showing improvements in the distance that boys could walk after taking the trialdrug (indicating improved lung function) a few months ago.
Recent setbacks for Sarepta
Sarepta has suffered a series of setbacks its efforts to win FDA approval for its MD drug, named eteplirsen. Last November, the FDA told Sarepta to not try for accelerated approval, which sent the share price tumbling and to an outcry from numerous families who believe it could be a breakthrough medication for the incurable condition.
Recent study results and discussions with the FDA hinted that perhaps progress was being made on that front, but Sarepta Therapeutics Inc (NASDAQ:SRPT) remained under a cloud given that a number of important employees have left in recent months. Just last week, the chief scientific officer was fired after less than a year after raising concerns with board members about CEO Chris Garabedian’s managerial moves.
The article in the Wall Street Journal also noted that the turnover in employees had caused the BoD to reduce Garabedian’s role in regulatory and medical affairs, as specifically, his participation in discussions with the FDA.
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares are trading up $2.70 at $23.13 as of 12:36 PM ET Wednesday.
