EXCLUSIVE-US FDA to request Sarepta to stop all shipments of gene therapy Elevidys, source says

By Bhanvi Satija

July 18 (Reuters) - The U.S. Food and Drug Administration will request Sarepta Therapeutics SRPT.O to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.

The FDA's request follows the death of two teenage boys who received Elevidys, a gene therapy approved in the United States to treat a muscle-wasting condition called Duchenne muscular dystrophy.

Both the boys were non-ambulatory patients, or those who could not walk independently, and in June, Sarepta had stopped shipments of the therapy to that patient group.