Yesterday, Sarepta Therapeutics announced a temporary, voluntary pause on all U.S. shipments of ELEVIDYS for the Duchenne population (both ambulatory and non-ambulatory), effective at the close of business today.
According to the press release, this measure is intended to allow Sarepta and the FDA to address information requests and update the ELEVIDYS safety labeling supplement process.
We recognize that this news will deeply affect many in our community, especially those who were anticipating treatment in the near future. Our thoughts are with all of you during this incredibly difficult time. With so many updates and developments over the past week, please know that we are committed to keeping you informed every step of the way.
You can read more in their Community Letter below and in their press release here: https://investorrelations.sarepta.com/news-releases/news-release-details/sarepta-therapeutics-announces-voluntary-pause-elevidys
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July 21, 2025
Dear Duchenne Community,
This evening, Sarepta has made the difficult decision to voluntarily and temporarily pause all U.S. shipments of ELEVIDYS effective at the end of the day tomorrow, including for ambulatory patients. This step will provide Sarepta with time to fully respond to any requests from the agency as we seek to update the label for ELEVIDYS. We believe this approach will provide a forum for a collaborative, science-driven review process with the agency.
You can read more in our statement here.
Please know that this decision was not made lightly. We know some of you were scheduled or taking steps to receive therapy. We share as much information as possible in real time with your physicians and this community. We are doing all we can to ensure the future availability of this therapy because we believe that patients and families should have choices and we hear the stories of the real difference it’s making for your loved ones.
Regards,
Wendy Erler Senior Vice President, Patient Affairs
