Food and Drug Administration Commissioner Dr. Robert Califf in Washington, D.C. on Sept. 14, 2022. An FDA advisory panel voted 14-1 Wednesday to recommend pulling preterm birth drug Makena from the market, voting it is not effective at helping prevent preterm births. Photo by Bonnie Cash/UPI | License Photo
Oct. 19 (UPI) -- An FDA advisory panel Wednesday vote recommended taking Makena, a drug for preventing premature births, off the market due to doubts about the drug's effectiveness. The FDA will make the final decision.
The 14-1 vote by the FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee was taken after a hearing. The committee voted no on whether the drug was effective, whether trial data support its approval and whether the drug should remain available on the market.
Peter Stein directs the FDA's Office of New Drugs at the Center For Drug Evaluation and Research.
"Hope is a reason to keep looking for options that are effective, whether we find them here or elsewhere," Stein said in closing remarks at the committee hearing. "Hope is not a reason to take a drug that is not shown to be effective, or keep it on the market.
Makena was fast-tracked 11 years ago to cut the risk of preterm birth, a leading cause of infant mortality.
A 2003 study cited by CovisPharma, the maker of Makena, showed Black newborns are more than twice as likely to die as White newborns when born before 37 weeks. Covis argued that pulling the drug from the market would hurt Black women.
If FDA follows the advisory committee's advice, which it usually does, it would be the first time in a decade that a fast-tracked drug would be pulled from the market.
The committee vote recommending stopping the sale of the drug relied largely on a 2019 clinical trial of over 1,500 women who got injections of Makena or a placebo at 16 weeks of pregnancy. It found that the drug was not effective at preventing preterm births.
In a statement earlier this year about the drug, Covis Pharma said it wanted to work with the FDA to do more research on Makena.
"We are committed to further study to clarify the risk-benefit of this drug, given the inconsistent efficacy outcomes between the landmark Meis study and PROLONG, and the important role Makena plays in this high-risk and underserved patient population," said Covis CEO Michael Porter in that June 2022 statement. "This need for further study is underscored by the very fact that there are no approved alternatives available for high-risk patients -- who for over a decade have been relying on this product and its generic versions to help carry their babies to term."