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# Sarepta Reports Death Linked to Elevidys
- URL: https://www.fdaweb.com/sarepta-reports-death-linked-to-elevidys/
- Published: 2025-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:55:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158840

Sarepta Therapeutics says that a young man with Duchenne muscular dystrophy (DMD) died following treatment with the company’s Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for DMD patients. A company [statement](https://investorrelations.sarepta.com/static-files/0d505d91-6722-4528-aae0-1e99fcbc37e5?ref=fdaweb.com) says the patient suffered acute liver failure. It says that acute liver injury is a known possible Elevidys side effect that is highlighted in the labeling.

“Although it is not a new safety signal and the benefit-risk of Elevidys remains positive, acute liver failure leading to death represents a severity of acute liver injury not previously reported for Elevidys, which to date has been used to treat more than 800 patients in clinical trials or as a prescribed therapy,” the statement says.

It says testing indicated the patient had a recent cytomegalovirus infection, which was identified by the treating doctor as a possible contributing factor.

Sarepta says the death has been reported to relevant health authorities, clinical study investigators, and prescribing doctors.