FDA outlines regulatory path for drisaperson

|By:, SA News Editor

The FDA clarifies an accelerated approval pathway for Prosensa Holdings' (RNA) Duchenne Muscular Dystrophy drug drisapersen based on existing data. The company plans to file its NDA later this year and commits to two confirmatory post-approval studies.

Prosensa will follow through on its plan to re-dose an initial cohort of boys in Q3 who have previously participated in drisapersen clinical studies.

Shares are up 13% premarket on fair volume.

Also benefiting from the good news is Sarepta Therapeutics' (SRPT) eteplirsen. The company also plans to file its NDA by year end.