Results, Setbacks

Years after it was OK’d, AMAG’s drug for preventing preterm births fails badly in long-awaited confirmatory trial

Eight years after the FDA offered its controversial OK for a drug dubbed Makena to prevent preterm births, the drugmaker who now controls it says the confirmatory study — begun a decade ago — is finally complete.

And it failed — miserably.

Waltham, MA-based AMAG Pharmaceuticals {$AMAG} noted that the Phase IIIb Makena trial was demanded by the FDA as part of an accelerated approval process that set the stage for the quick rollout of Makena, or 17p, an old drug dating back to the 1950s that had been sold for just a few dollars a dose by compounding pharmacies.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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