FDA Reverses Course, Allows Sarepta’s Duchenne Gene Therapy for Younger Patients

In a significant and swift reversal, the U.S. Food and Drug Administration (FDA) announced on Monday that it has cleared Sarepta Therapeutics to resume shipments of its gene therapy, Elevidys, for Duchenne muscular dystrophy. The decision specifically applies to younger Duchenne patients who retain the ability to walk.

This move comes after a brief, voluntary hold on the therapy’s distribution. The FDA stated it would continue to collaborate with Sarepta regarding non-ambulatory patients, which remains subject to a voluntary hold following two reported deaths.

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