Eteplirsen Approval Reflected FDA's Conflict On Accelerated Approval

Eteplirsen Approval Reflected FDA's Conflict On Accelerated Approval – Former Sarepta CEO

28 Dec 2016

There is anxiety within the US agency over use of the pathway amid the prospect for confirmatory trials to fail, former CEO Garabedian says at FDA/CMS Summit.

The regulatory review of Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy drug Exondys 51 (eteplirsen) highlighted FDA staff's conflicted feelings about the accelerated approval pathway, the company's former CEO said Dec. 14.

"I think it's fair to say that there are probably some within the FDA who see the accelerated approval pathway...