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Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial

 
• By Sue Sutter

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.

Path of plated stones on gravel bed in Japanese Garden. Meditative stone walkway. Garden architecture, pathway accessory to garden pond.
US FDA is pursuing withdrawal so as not to damage the integrity of the accelerated approval pathway. • Source: Shutterstock

Citing a failed confirmatory trial as well as the “integrity” of the accelerated approval process, the US Food and Drug Administration is seeking to remove AMAG Pharmaceuticals Inc.'s preterm birth prevention drug Makena (hydroxyprogesterone caproate) from the market.

On 5 October, the Center for Drug Evaluation and Research announced its proposal to withdraw Makena, along with its generic equivalents, because the confirmatory study required as a condition of accelerated approval failed to verify clinical

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