Roche Pauses Shipments of Muscular Disorder Gene Therapy Elevidys Amid Safety Concerns
Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a similar move by U.S. partner Sarepta Therapeutics. The decision comes after the FDA requested a pause following the death of a patient undergoing the treatment.
Roche Holding AG announced a temporary suspension of Elevidys gene therapy shipments in certain countries outside the United States, mirroring the stance of its U.S. collaborator, Sarepta Therapeutics. The Swiss pharmaceutical giant's decision reflects growing safety concerns surrounding the muscular disorder treatment.
The shipping hiatus, effective immediately, affects new orders of Elevidys in nations that regard FDA approval as essential for local acceptance. Still, Roche will continue distributing to regions where the therapy remains authorized, strictly in coordination with local regulatory bodies.
This development follows Sarepta's compliance with an FDA request to halt U.S. shipments after a patient suffering from acute liver failure died, the third fatality linked to the gene therapy this year. Roche is actively engaging with global health authorities to decide on future actions.
(With inputs from agencies.)
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