FDA declines to approve Sarepta's second Duchenne drug

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REUTERS: The U.S. Food and Drug Administration declined to approve Sarepta Therapeutics Inc's newest treatment for Duchenne muscular dystrophy ...

REUTERS: The U.S. Food and Drug Administration declined to approve Sarepta Therapeutics Inc's newest treatment for Duchenne muscular dystrophy , a rare muscle-wasting disorder that mainly affects boys, the company said on Monday.

The health agency cited safety concerns, including risk of infection and kidney toxicity. The Cambridge, Massachusetts-based company already has one approved treatment for DMD on the market.

 

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