Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, announced it has voluntarily and temporarily halted all shipments of ELEVIDYS (delandistrogene moxeparvovec) in the United States, effective July 22, 2025. ELEVIDYS is a treatment for Duchenne muscular dystrophy (DMD).
The pause is a proactive measure to allow Sarepta time to respond to potential FDA information requests and to complete the safety labeling supplement review process for ELEVIDYS. The company emphasized its commitment to collaborating closely with the FDA through a science-driven review.
Doug Ingram, CEO of Sarepta, acknowledged the difficult nature of the decision, noting the urgent needs of DMD patients who are losing muscle function daily. He said, “Maintaining a productive working relationship with the FDA is essential, and this temporary pause will help address their questions and finalize the labeling process.”
Sarepta reassured patients, families, and healthcare providers that it remains dedicated to transparency and patient safety, promising timely updates as new information arises.