Sarepta announces FDA’s approval of updated Elevidys Prescribing Information

Sarepta Therapeutics

14 November 2025 - Sarepta Therapeutics today announced an update to the prescribing information for Elevidys (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy.

As previously disclosed, the Elevidys label now includes several key updates, including. a boxed warning for the risk of acute serious liver injury and acute liver failure.

Read Sarepta Therapeutics press release

Michael Wonder

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Michael Wonder

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Outcome , US , Registration , Gene therapy