(Reuters) -Roche Holding AG paused all shipments of the controversial gene therapy Elevidys, Bloomberg News reported on Tuesday. (Reporting by Disha Mishra in Bengaluru; Editing by Alan Barona)
Roche Halts Elevidys Gene Therapy Shipments Outside the U.S.
(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)
