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Sarepta's Additional Data Doesn't Sway FDA On Eteplirsen

 
• By Derrick Gingery

Agency reviewers raise more concerns about efficacy of proposed Duchenne muscular dystrophy treatment despite new information.

It does not appear additional data and time for review have improved the prospects for Sarepta Therapeutics Inc.'s proposed Duchenne muscular dystrophy treatment eteplirsen.

The product had already appeared to face long odds for approval when FDA released its initial briefing documents for eteplirsen's advisory committee, which had been scheduled for Jan. 22

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