FDA Approves Major Safety and Indication Updates for Sarepta's ELEVIDYS Gene Therapy
Sarepta Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved significant updates to the prescribing information for its Duchenne muscular dystrophy (DMD) gene therapy, ELEVIDYS (delandistrogene moxeparvovec-rokl). This regulatory action follows reports of serious adverse events, including fatal cases of acute liver failure in non-ambulatory patients treated with the therapy. The updated label now includes a Boxed Warning, the FDA's most prominent safety alert, detailing the risk of acute serious liver injury and acute liver failure.
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