Sarepta Therapeutics Inc (NASDAQ:SRPT)

Discussion in 'Men's Economics' started by Michael Scally MD, Oct 13, 2012.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Sarepta Therapeutics Announces FDA Considers NDA Filing for Eteplirsen Premature in Light of Recent Competitive Drug Failure and Recent DMD Natural History Data
    FDA Questions Dystrophin as a Biomarker Due to Failed Studies of Other Investigational Drugs for DMD; FDA Questions 6-Minute Walk Test Results for Eteplirsen, Suggesting Study Population Should Be Stable Over Two-Year Timeframe Due to Recent Natural History Data; FDA Requests Further Discussion on Endpoints, Design of Confirmatory Clinical Study.
    News Release |

    Citing recent developments since Sarepta's last meeting with the agency, including a failed study with a competitive product and recent natural history data in DMD, the FDA indicated the new data raise "considerable doubt" about both the dystrophin biomarker and the supportive clinical efficacy assessed on the 6-minute walk test (6MWT) in the Phase IIb clinical study of eteplirsen.

    As a result of these recent data, the FDA stated that they "currently consider an NDA filing for eteplirsen as premature."
  2. Michael Scally MD

    Michael Scally MD Doctor of Medicine