Roche has halted some international shipments of the gene therapy Elevidys, used to treat Duchenne muscular dystrophy, Bloomberg reported July 22.
The decision comes in the wake of a similar move by Sarepta Therapeutics, which developed the drug. The drugmaker said the voluntary pause affects new orders in countries that base drug approvals on FDA decisions and applies to all Duchenne muscular dystrophy patients.
Sarepta on July 22 paused U.S. distribution of Elevydis to address FDA requests and complete the agency’s safety labeling process. This comes after reports of multiple deaths, including two earlier in 2025 that were directly tied to Elevidys and another involving a different Sarepta gene therapy.
Roche said it will continue to ship Elevidys to markets that do not rely on FDA decisions for regulatory approval, such as Brazil and Japan, Bloomberg reported.
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