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Sarepta stumbles on FDA rejection of a new drug to treat Duchenne muscular dystrophy
Sarepta Therapeutics was dealt a surprising setback Monday when the Food and Drug Administration rejected its marketing application for a second drug that aimed to treat children with Duchenne muscular dystrophy, a rare, inherited muscle-wasting disease.
In a statement, Sarepta said the FDA denied the approval of its drug, called Vyondys 53, due to the risk of infections related to intravenous infusion ports and kidney toxicity seen in animal experiments.
