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5h ago

Sarepta Defies FDA Request to Halt Elevidys Shipments

The FDA’s call for a full suspension follows three liver injury deaths in its gene therapy trials.

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File)
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Overview

  • Sarepta will continue shipping Elevidys for ambulatory Duchenne muscular dystrophy patients despite the FDA’s informal request to suspend all deliveries.
  • The FDA has placed clinical trials for limb-girdle muscular dystrophy on hold and is reviewing safety data that include three fatalities linked to liver injury.
  • Non-ambulatory patient dosing of Elevidys remains paused as Sarepta updates packaging with warnings for acute liver risks.
  • The company announced nearly 500 layoffs, including 80 staff in Columbus, after its stock plunged over 30% amid the regulatory scrutiny.
  • Regulators are weighing a formal withdrawal of Elevidys as Sarepta negotiates ongoing discussions and enhanced safety monitoring with the FDA.