April 25, 2016 / 11:40 PM / 4 years ago

BRIEF-U.S. FDA panel votes Sarepta's DMD drug does not show substantial evidence of efficacy

April 25 (Reuters) -

* FDA’s Eric Bastings says “we are a science based organization” addressing dmd patients and parents

* 5 of 13 panelists vote Sarepta provided substantial evidence that drug helps produce Dystrophin to level that is likely to predict clinical benefit

* 8 of 13 panelists vote Sarepta didnt offer substantial evidence that drug helps produce Dystrophin to level that is likely to predict clinical benefit

* One FDA advisory panelist says he voted no by mistake on question two

* Finally, 6 panelists vote Sarepta provided substantial evidence that drug helps produce Dystrophin to level that is likely to predict clinical benefit

* U.S. FDA panel votes Sarepta’s Duchenne Muscular Dystrophy drug does not show substantial evidence of efficacy

* 7 panelists vote that Sarepta did not provide substantial evidence that eteplirsen is effective for DMD

* 3 panelists vote that Sarepta provided substantial evidence that eteplirsen is effective for dmd; 3 did not vote

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