Withdrawing Approval of Makena — A Proposal from the FDA Center for Drug Evaluation and Research

This article presents the rationale behind the FDA Center for Drug Evaluation and Research's proposal to withdraw approval of Makena, a drug previously authorized to prevent recurrent preterm birth. Although initial trial data (Trial 002) showed reduction in preterm births, a larger confirmatory trial (Trial 003) failed to demonstrate clinical benefit, either in reducing preterm births or improving neonatal outcomes. The authors argue that the lack of efficacy warrants withdrawal of the drug from the market despite its prior accelerated approval.

This article presents the rationale behind the FDA Center for Drug Evaluation and Research's proposal to withdraw approval of Makena, a drug previously authorized to prevent recurrent preterm birth. Although initial trial data (Trial 002) showed reduction in preterm births, a larger confirmatory trial (Trial 003) failed to demonstrate clinical benefit, either in reducing preterm births or improving neonatal outcomes. The authors argue that the lack of efficacy warrants withdrawal of the drug from the market despite its prior accelerated approval.