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KV's Gestiva Reemerges With New Name, Makena, And A Long-Sought FDA Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

Approval of the pre-term birth prevention therapy could pull KV Pharmaceutical back from the brink.

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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.

Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October

Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.

Makena Might Stay On Market Despite Failed Confirmatory Trial In Pre-Term Birth

Subgroup analyses by AMAG may support ongoing use, but the once-controversial Makena seems unlikely to be pulled from the US market in any event since compounded progesterone is the only alternative therapy.

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