The US Food and Drug Administration is relying on enhanced pharmacovigilance and a label warning to address one of the safety concerns that Sarepta Therapeutics Inc. said delayed approval of its Duchenne muscular dystrophy drug Vyondys 53 (golodirsen).
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
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