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Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing

 
• By Sue Sutter

The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.  

Narrow path
Covis' preferred path for Makena is to narrow the current indication while conducting a new randomized, controlled trial. • Source: Shutterstock

Covis Pharma is proposing to narrow the current indication for its preterm birth prevention drug Makena (hydroxyprogesterone caproate or 17-OHPC), limiting its use to high-risk patients while it conducts a new randomized, controlled trial in the US.

However, the US Food and Drug Administration's Center for Drug Evaluation and Research stands in opposition, saying the drug should come off the market because the confirmatory trial failed, the drug carries

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