FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients
United States, July 28 -- The U.S. Food and Drug Administration is recommending the removal of the voluntary hold for ambulatory patients who may now receive Elevidys, a Sarepta Therapeutics gene therapy for Duchenne Muscular Dystrophy (DMD). The FDA's investigation has concluded that the death of the 8-year-old boy is unrelated to the gene therapy product itself. The FDA will continue to work with the sponsor regarding non ambulatory patients, which remains subject to a voluntary hold, following two deaths.The patient community is an important voice, and the FDA will continue to listen to and respond to thoughts from the community impacted by DMD.Elevidys is an adeno-associated virus vector-based gene therapy using Sarepta Therapeutics, In...
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