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Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA

 
• By Sue Sutter

AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.

Sand in hourglass
AMAG wants more time to gather confirmatory data for Makena. • Source: Shutterstock

AMAG Pharmaceuticals Inc. has laid out its case for keeping Makena (hydroxyprogesterone caproate) on the market under accelerated approval while it conducts retrospective and observational studies, and possibly even another randomized, placebo-controlled trial, of the drug for preventing recurrent preterm birth.

In a recent submission to the US Food and Drug Administration, AMAG presents its most publicly detailed proposals to date...

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