FDA votes to withdraw approval of premature birth prevention drug


An advisory panel for the US Food and Drug Administration voted 14-1 to withdraw 17α-hydroxyprogesterone caproate (Makena; Covis Pharma) from the market.

A US Food and Drug Administration (FDA) advisory panel has voted 14 to 1 to withdraw 17α-hydroxyprogesterone caproate (Makena; Covis Pharma) for the prevention of preterm birth from the market.1

Panelists agreed with the 2020 decision by the FDA that deemed the injectable drug ineffective, citing evidence from the confirmatory trial, the PROLONG study.2

The study included 1700 patients and showed that Makena did not have a statistically significant effect on preterm births before 35 weeks gestation (relative risk [RR] 0.95, 95% CI 0.71-1.26) or a neonatal composite index that included outcomes such as death, respiratory distress syndrome, bronchopulmonary dysplasia, and sepsis, among others (RR 1.05, 95% CI 0.68-1.61).

The FDA’s briefing materials note that the benefit-risk calculation for Makena was not favorable, as the medication is ineffective and carries risks for adverse events like blood clots or depression.

“If we allow Makena to remain on the market, it implies the FDA looked at a large study, found no benefit and yet allowed this drug to stay on the market," said Margery Gass, MD, an ob-gyn at Cleveland Clinic and one of the FDA advisory panelists. “I think that’s a bad precedent.”

Is it expected that Robert Califf, MD, FDA commissioner, will make a final decision on the withdrawal of the drug within the next few months. This would be the first time the FDA formally pulled a drug from the market following approval based on early data if Califf follows through with the advisory panel’s advice.

The injectable drug was approved for pregnant women with a history of at least 1 spontaneous preterm birth. Initially, the FDA approved Makena in 2011 to reduce the risk of preterm birth before 37 weeks of pregnancy among women who had a history of spontaneous preterm birth. The drug was under accelerated approval, which allows the agency to expedite the approval process based on a surrogate endpoint thought to predict clinical benefit.

The initial approval was based on clinical trial results, during which women received a 250-mcg injection of Makena and had a significantly lower risk of delivering before 37 weeks compared with the placebo group. However, since the risk reduction in preterm births did not signify a direct clinical benefit to babies born prematurely, the FDA required a post-marketing confirmatory trial.

This article was published by our sister publication Contemporary OB/GYN.


  1. FDA panel backs removal of unproven pregnancy drug. October 19, 2022. Accessed October 19, 2022. https://news.yahoo.com/fda-panel-backs-removal-unproven-150245703.html
  2. Carr L.FDA plans to remove hydroxyprogesterone caproate approval. Contemporary OB/GYN. October 17, 2022. Accessed October 19, 2022. https://www.contemporaryobgyn.net/view/fda-plans-to-remove-hydroxyprogesterone-caproate-approval
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