AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?

Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.

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AMAG offered a somewhat circular argument as to why Makena's confirmatory trial failed. • Source: Shutterstock

The failed confirmatory trial for AMAG Pharmaceuticals Inc.'s Makena leaves the US Food and Drug Administration with a no-win decision on whether to withdraw the only approved drug for preventing recurrent preterm birth.

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