Sarepta Suspends Gene Therapy Shipments After Tragic Deaths
Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular dystrophy died of liver failure. The suspension follows an FDA request and affects non-ambulatory patients. Sarepta's stock fell 8.6%, and clinical trials for limb girdle muscular dystrophy are on hold.
Sarepta Therapeutics announced on Monday a halt to all U.S. shipments of Elevidys, a gene therapy, following the deaths of two teenagers suffering from Duchenne muscular dystrophy due to liver failure. The U.S. Food and Drug Administration had requested the suspension, leading Sarepta to stop supplying non-ambulatory patients.
On the stock market, Sarepta saw an 8.6% drop to $12.17 after hours, post-disclosure of a third death involving similar technology. As a result, Sarepta's clinical trials for limb girdle muscular dystrophy are now on hold due to serious safety concerns. Sarepta plans a temporary shipment pause of Elevidys for Duchenne muscular dystrophy by Tuesday.
The pause will give Sarepta time to address FDA inquiries and review safety labeling concerning Elevidys. Previous warnings related to acute liver injury for mobile DMD patients resulted in job cuts and halted developments for related therapies. Children's Hospital Los Angeles similarly suspended Elevidys usage.
(With inputs from agencies.)
ALSO READ
Health Sector Developments: Trump’s Bill, Major Mergers, and FDA Approvals
Biocon Biologics Secures USFDA Nod for Groundbreaking Diabetes Treatment
Sarepta Defies FDA Order Amidst Gene Therapy Controversies
Scrutiny Intensified: FDA Calls Halt on Sarepta's Gene Therapy Amid Safety Concerns
Health Headlines: FDA Panel Rejects PTSD Drug, Getinge Tops Profits, Bird Flu Hits Spain
Google News