Roche pauses shipments of Elevidys gene therapy outside US

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(Reuters) -Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics.

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.

Roche said it would continue to ship the treatment for ambulatory patients in other countries where it is approved, in consultation with local regulatory authorities.

Elevidys is approved in countries including Japan, United Arab Emirates, Qatar and Kuwait.

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.

Sarepta late on Monday said it would comply with a request from the FDA to pause all shipments of Elevidys in the United States.

The FDA’s request came after the company disclosed on Friday that another patient who had received its experimental gene therapy died from acute liver failure, marking the third death this year for Sarepta after two teenage boys who had received Elevidys also died.

Roche said it is working to understand why the FDA has made the request and that it is in contact with health authorities globally to determine next potential steps.

Roche acquired the commercial rights to Sarepta’s Elevidys outside the United States in 2019.

Bloomberg News first reported the development.

(Reporting by Mariam Sunny and Mrinmay Dey in Bengaluru; Additional reporting by Disha Mishra in Bengaluru; Editing by Alan Barona)