India, July 26 -- The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a gene therapy developed by Sarepta Therapeutics for Duchenne muscular dystrophy. The death occurred on June 7, 2025. In response, the FDA requested-and received-a voluntary suspension of product distribution while it investigates safety concerns. However, Sarepta Therapeutics stated that the patient's death was deemed unrelated to treatment with ELEVIDYS.
Elevidys is an adeno-associated virus vector-based gene therapy using Sarepta Therapeutics, Inc.'s AAVrh74 Platform Technology for the treatment of Duchenne muscular dystrophy. The product is administered as a single intravenous dose.
Duchenne muscular dystrophy...