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Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA

 
• By Sue Sutter

Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.

FDA Advisory Committee Feature image

The US Food and Drug Administration’s difficult decision on whether to withdraw accelerated approval for AMAG Pharmaceuticals Inc.'s Makena or keep the preterm birth drug on the market may have been made more challenging by a split advisory committee vote.

On 29 October, nine of 16 members of the Bone, Reproductive and Urologic Drugs Advisory Committee voted that the agency should pursue withdrawal of approval for Makena (hydroxyprogesterone caproate injection, also known as HCP or 17P)

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