Gene Therapy Maker Sarepta Tells FDA It Won’t Halt Shipments Despite Patient Deaths

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

WASHINGTON (AP) — Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of its gene therapy. The Food and Drug Administration made the request Friday after the confirmation of a third death receiving one of its treatments for muscular dystrophy. The company’s decision not to comply is highly unusual. The FDA says officials met with Sarepta executives and requested the halt in sales. Sarepta says in a statement that its scientific review showed no new safety concerns for younger patients with Duchenne’s muscular dystrophy. The company said it plans to keep the drug, Elevidys, available for those patients.