Drugmaker Declines FDA Request to Pull Treatment After Patient Deaths

Sarepta stopped shipping Elevidys to non-ambulatory patients earlier this year.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Sarepta Therapeutics will not agree to a regulatory request to pause shipments of a treatment for muscular dystrophy in the wake of patient deaths, the pharmaceutical company said on July 18 after receiving the request.

“Based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals in the ambulant patient population, we will continue to ship Elevidys to the ambulant population,” Sarepta said in a statement.