Roche pauses shipments of Elevidys gene therapy outside US
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.
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