Monday, July 21, 2025

Be very mindful of the pharmaceuticals you take

Sarepta Refuses FDA Request To Halt Elevidys After Three Deaths

BY TYLER DURDEN
MONDAY, JUL 21, 2025 - 02:45 AM

Sarepta Therapeutics Inc. has refused a request from the U.S. Food and Drug Administration to halt all shipments of its gene therapy Elevidys after three patient deaths, Bloomberg reported this weekend.

The FDA disclosed that two teenage boys with Duchenne muscular dystrophy, both unable to walk, died recently from acute liver failure after receiving Elevidys. In addition, a 51-year-old participant in a trial of a different Sarepta gene therapy targeting limb-girdle muscular dystrophy died last month, also of acute liver failure.

Bloomberg writes that following these events, FDA officials met with Sarepta and asked the company to voluntarily pause shipments of Elevidys, which accounts for more than half the company’s product revenue. “The company refused to do so,” the agency stated.

Sarepta, in its own statement Friday, defended its decision to continue distribution “based on our comprehensive scientific interpretation of the data, which shows no new or changed safety signals” in patients who are still ambulatory.

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