FDA declines to approve Sarepta’s second Duchenne drug

(Reuters) – The U.S. Food and Drug Administration declined to approve Sarepta Therapeutics Inc’s newest treatment for Duchenne muscular dystrophy (DMD), 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.

Reporting by Manas Mishra in Bengaluru; Editing by Anil D’Silva

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