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

Executive Summary

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

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.

Accelerated Approval Under Review By US FDA: Completing Confirmatory Trials A Focus

Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’

FDA Requests Withdrawal Of Makena And Generics

Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.

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