Roche Halts Elevidys Distribution in Several Countries Following Sarepta and FDA Safety Concerns

Roche has temporarily and voluntarily stopped shipments of Elevidys, a Duchenne muscular dystrophy gene therapy, in certain countries outside the U.S., particularly those that reference the FDA for their approval decisions1234.

This action follows Sarepta Therapeutics' pause of Elevidys shipments in the U.S. at the FDA's request after reports of two patient deaths from acute liver failure and additional safety concerns25.

Countries that approved Elevidys independently of the FDA, such as Brazil and Japan, will continue to receive shipments for ambulatory (walking) patients only124.

To date, there have been no treatment-related deaths reported in ambulatory patients treated with Elevidys according to Roche, who continues to assert a positive benefit-risk profile for this population4.

Roche and Sarepta are engaging with regulators to determine next steps and are in ongoing discussions with health authorities globally24.

Sources:

1. https://www.statnews.com/2025/07/23/roche-sarepta-gene-therapy-elevidys-duchenne-safety/

2. https://www.biopharmadive.com/news/roche-elevidys-pause-some-shipments-duchenne-sarepta/753817/

3. https://www.bloomberg.com/news/articles/2025-07-22/roche-pauses-shipments-of-contested-gene-therapy-outside-the-us

4. https://www.biospace.com/business/following-sareptas-lead-roche-suspends-elevidys-shipments-to-some-ex-us-countries

5. https://www.neurologylive.com/view/third-patient-death-leads-significant-concerns-sarepta-gene-therapy-program