Published by Global Banking & Finance Review®
Posted on July 22, 2025
1 min readLast updated: January 22, 2026
Add as preferred source on GoogleRoche pauses global shipments of Elevidys gene therapy, affecting Duchenne muscular dystrophy patients, due to FDA-related concerns.
(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)
Roche has paused all shipments of Elevidys outside the U.S. due to a decision that echoes a similar move by its partner, Sarepta Therapeutics.
No, the pause is voluntary and temporary, affecting all patients with Duchenne muscular dystrophy.
Roche acquired the commercial rights to Sarepta's Elevidys outside the United States in 2019.
Elevidys is a gene therapy designed to treat Duchenne muscular dystrophy, a muscular disorder.
Bloomberg News was the first to report the development regarding Roche's pause on Elevidys shipments.
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