Sarepta wins surprise approval for second Duchenne muscular dystrophy drug

Walter Davidson December 13, 2019

Sarepta wins surprise approval for second Duchenne muscular dystrophy drug

Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

The FDA had previously rejected Sarepta’s application for Vyondys 53 in August, citing infections and kidney toxicity in preclinical studies. However, some analysts saw the move as a ‘slap on the wrist’ for the controversial approval of Sarepta’s first DMD drug.



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