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FDA asks for additional info on Sarepta's muscular dystrophy drug
April 15, 2013 / 8:46 PM / 4 years ago

FDA asks for additional info on Sarepta's muscular dystrophy drug

April 15 (Reuters) - Sarepta Therapeutics Inc said U.S. health regulators have asked for additional information on its experimental drug intended to treat young boys suffering from a rare degenerative disease.

Shares of the company were down 6 percent at $36.78 in extended trading on Monday.

The U.S. Food and Drug Administration asked for additional information on the drug, eteplirsen, to consider early approval.

The feedback from the FDA was provided after the drug significantly improved walking ability in a mid-stage trial for patients with Duchenne Muscular Dystrophy (DMD).

DMD is a rare genetic disorder that appears as early as infancy in male children and leads to severe muscle loss and eventual death.

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