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

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