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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...

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