FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys

For Immediate Release:: July 25, 2025

The U.S. Food and Drug Administration is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and received voluntary suspension of product distribution as it investigates the safety concerns.

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 is a rare genetic condition characterized by progressive muscular weakness. The disease occurs due to a defective gene.

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