FDA: Too early for Sarepta to file for approval of Eteplirsen
- The FDA says that Sarepta's (SRPT) submission of a New Drug Application (NDA) for the company's Eteplirsen drug for the treatment of Duchenne muscular dystrophy (DMD) is premature following the failure of GlaxoSmithKline's and Prosensa's Drisapersen product in a Phase III trial.
- The FDA also indicated that - in Sarepta's words - "new data raise 'considerable doubt' about the dystrophin biomarker and the supportive clinical efficacy assessed on the 6-minute walk test (6MWT) in the Phase IIb clinical study of Eteplirsen."
- Last month, SA author EnhydrisPECorp predicted that the FDA wouldn't grant early approval of Eteplirsen.
- Shares are -29%. (PR) (Q3 results)
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