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# FDA to Demand New Elevidys Safety Data from Sarepta
- URL: https://www.fdaweb.com/fda-to-demand-new-elevidys-safety-data-from-sarepta/
- Published: 2025-07-24T12:00:00.000Z
- Updated: 2026-09-14T15:17:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159568

FDA reportedly will require additional safety data from Sarepta Therapeutics before the agency considers supporting the continued use of the company’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec-rokl) following three recent patient deaths — two associated with Elevidys and the other associated with an experimental gene therapy for limb-girdle muscular dystrophy, which uses the same AAVrh74 viral vector as the DMD treatment. Its continued use in the U.S. market is contingent on data that will assure the agency that the therapy’s use will not result in more deaths, an unnamed FDA official told [*Bloomberg*](https://www.google.com/url?sa=t&source=web&rct=j&opi=89978449&url=https://www.bloomberg.com/news/articles/2025-07-23/sarepta-needs-to-show-fda-elevidys-won-t-cause-more-deaths&ved=2ahUKEwiYy5qGt9aOAxVLLFkFHVn-I8kQxfQBKAB6BAgMEAE&usg=AOvVaw1SYJsTHNg5nUsVIWw6IgyV), adding that the company will have to produce a detailed plan as to how it can be safely reintroduced.

Earlier this week, Sarepta [reluctantly agreed](https://www.fdaweb.com/fda-wins-as-sarepta-folds-and-stops-shipping-elevidys/) to an FDA request to pause all shipments of Elevidys in the U.S. “This proactive step will allow Sarepta the necessary time to respond toany requests for information and allow Sarepta and FDA to complete the Elevidys safety labeling supplement process,” the company said at the time.

The FDA official told *Bloomberg* that the agency has yet to see a convincing account as to why Elevidys was tied to the two liver failure fatal cases, adding that there may be no simple fix to the problem. There are no FDA employees who support Elevidys’s return to the market based on current data, *Bloomberg* reported.

Asked to confirm that FDA will require new clinical data before allowing Sarepta’s Elevidys back on the market, an HHS spokesperson said: “We are looking at all the tools we have.”