The Food and Drug Administration will ask Sarepta Therapeutics to stop shipping its gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to BioPharma Dive.
The request comes as the FDA investigates the safety risks of the therapy, called Elevidys, after the deaths of two teenagers treated with it earlier this year. Sarepta this week disclosed the death of another patient with a different kind of muscular dystrophy who received a similar, experimental gene therapy.
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