Digging In To Sarepta's FDA Victory

April 21, 2014 11:00 AM

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In a second dramatic reversal for a promising treatment for a terrible disease, Sarepta Therapeutics announced that it will file an application with the Food and Drug Administration for its drug eteplirsen, to treat Duchenne muscular dystrophy that is caused by a specific mutation, by the end of 2014. The news should please both investors and patient advocates who have campaigned for the drug’s approval.

Last November, Sarepta shares plummeted 64% in a day when the company said the FDA told the company that the data from its main study, an analysis of only 12 patients, was insufficient to ask for approval. Before that, Sarepta had strongly signaled that the FDA would review the drug based on that da...

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