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Accelerated Approval: Makena Real-World Evidence Insufficient To Verify Clinical Benefit, CDER Says

 
• By Sue Sutter

Covis seeks to discuss study proposals and other accelerated approval precedents at still-unscheduled withdrawal hearing; CDER says company’s current RWE proposal is inadequate given its design and the failure of the PROLONG confirmatory clinical trial.

Door closed
CDER has closed the door on any bid by Covis to rely solely on real-world evidence to confirm Makena's clinical benefit. • Source: Alamy

Covis Pharma cannot rely on real-world evidence alone to confirm the clinical benefit of the preterm birth prevention drug Makena (hydroxyprogesterone caproate), the US FDA’s Center for Drug Evaluation and Research said.

At the forthcoming hearing on CDER’s proposal to withdraw Makena’s accelerated approval, Covis seeks to discuss precedent for agency reliance on RWE in regulatory decision-making

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