FDA Lifts Hold on ELEVIDYS for Ambulatory Duchenne Patients

The U.S. Food and Drug Administration has advised Sarepta Therapeutics that the voluntary pause on ELEVIDYS shipments can be lifted for ambulatory patients diagnosed with Duchenne muscular dystrophy. Sarepta is set to resume deliveries of Elevidys to care centers for those ambulatory individuals immediately. The FDA concluded its investigation into a June patient death in Brazil, determining it was not related to Elevidys treatment.

Note: The hold remains in place for non-ambulatory patients as a safety review for that group continues.

For more information, please contact your care team or visit www.sarepta.com.

Published on: 7/29/2025