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Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning

 
• By Sue Sutter

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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Vyondys 53 sped through the US FDA dispute resolution process on its way to an accelerated approval. • Source: Shutterstock

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).

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