The safety issue surrounding Sarepta Therapeutics' Duchenne muscular dystrophy drug Elevidys reached a tense point Friday when the biotech company rejected the FDA's request to halt all shipments of the gene therapy in the U.S. The FDA also revoked the platform designation for Sarepta's viral vector technology on Friday.
Today, Sarepta Therapeutics notified the U.S. Food and Drug Administration (FDA) of its decision to voluntarily and temporarily pause all shipments of ELEVIDYS (delandistrogene moxeparvovec) for Duchenne muscular dystrophy in the United States, effective close of business Tuesday, July 22, 2025.
Disclaimer: This article is for informational purposes only and does not provide medical advice. Patients and families should discuss treatment options and clinical trials with their healthcare professionals.
