Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling.
The drugmaker said the pause, effective July 22, will allow time to respond to FDA inquiries and complete the agency’s safety labeling supplement process, according to a July 21 news release.
The decision comes after the FDA requested the drugmaker pause distribution of the drug earlier this week, following reports of multiple patient deaths. Two deaths earlier in 2025 were tied directly to Elevidys, the only FDA-approved gene therapy for Duchenne. Sarepta said a third patient, who died of acute liver failure, had been enrolled in a separate early stage trial for another Sarepta gene therapy.
Sarepta initially said it would continue shipping Elevidys despite the FDA’s request, citing that there were no new or changed safety signals in ambulant patients based on internal review.
