Sarepta stumbles on FDA rejection of a new drug to treat Duchenne muscular dystrophy
Sarepta Therapeutics was dealt a surprising setback when the FDA rejected its application for a second Duchenne muscular dystrophy drug.
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
