Sarepta Gets FDA Approval of Treatment for Duchenne Muscular Dystrophy
By Ben Glickman
Sarepta Therapeutics said Thursday that the company had received U.S. Food and Drug Administration approval of its treatment for Duchenne muscular dystrophy.
The Cambridge, Mass.-based genetic medicine company said Elevidys, a gene therapy for treating four- and five-year-old patients with DMD, had received accelerated approval from the FDA. The company said Elevidys was the first approved treatment for the disease.
DMD is a degenerative muscle disease caused by a genetic mutation. The disease primarily affects children.
The approval is contingent on successful confirmatory trials of the treatment. The results of an additional trial are expected in late 2023, the company said.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
June 22, 2023 14:33 ET (18:33 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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