Sarepta Receives Negative CHMP Re-examination Opinion for Eteplirsen
Sarepta Therapeutics, Inc. (SRPT)
Last sarepta therapeutics, inc. earnings: 2/26 04:05 pm
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Source: GlobeNewswire
-- Relying upon Scientific Advisory Group input, Sarepta will seek further scientific advice from European Medicines Agency on a possible path to bring eteplirsen to patients in Europe -- CAMBRIDGE, Mass., Sept. 21, 2018 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a commercial-stage biopharmaceutical company focused on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has confirmed its 31 May 2018 negative opinion for a Conditional Marketing Application for eteplirsen. Eteplirsen is designed to treat approximately 13% of the Duchenne muscular dystrophy community who have genetic mutations amenable to exon 51 skipping. “While largely anticipated, we are disappointed with the outcome of the CHMP re-examination and firmly believe that eteplirsen should be made available to patients in Europe, as
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