Roche pauses shipments of Elevidys gene therapy outside US
Roche pauses shipments of Elevidys gene therapy outside US
Published by Global Banking and Finance Review
Posted on July 22, 2025
Published by Global Banking and Finance Review
Posted on July 22, 2025
(Reuters) -Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics on Tuesday.
The Swiss drugmaker said the pause, effective Tuesday, applies to new orders of Elevidys in countries outside the U.S. that reference the Food and Drug Administration as the basis for their local approval.
The pause is voluntary and temporary, and applies to all patients with Duchenne muscular dystrophy regardless of their ability to walk, Roche said in an emailed statement.
Roche acquired the commercial rights to Sarepta's Elevidys outside the United States in 2019.
Bloomberg News first reported the development.
(Reporting by Disha Mishra and Mariam Sunny in Bengaluru; Editing by Alan Barona)
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