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CDER Opposes Covis’ Bid To Steer Focus Away From Makena's Failed Confirmatory Trial

 
• By Sue Sutter

The company offered to stipulate that findings from the PROLONG trial do not verify clinical benefit of the preterm birth prevention drug; the US FDA’s drugs center opposed a stipulation, saying failure of a confirmatory trial to verify clinical benefit is an independent ground for withdrawing accelerated approval and an advisory committee should vote on the question.

Steering wheel
Covis sought to steer attention away from Makena's failed confirmatory study. • Source: Shutterstock

Covis Pharma appears to have lost its bid to steer attention away from the failed PROLONG confirmatory trial at the forthcoming US Food and Drug Administration public hearing on Makena’s (hydroxyprogesterone caproate) continued accelerated approval.

The FDA’s Center for Drug Evaluation and Research disagreed with Covis’ proposal to stipulate that the findings from PROLONG (Trial 003) do not verify Makena’s clinical benefit on

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