FDA panel recommends pulling Makena, citing ineffectiveness of controversial preterm birth drug
Federal health advisers recommended Wednesday that a drug meant to prevent premature births be taken off the market because it has not been shown to be effective.
The Food and Drug Administration’s advisory panel, made up of gynecologists, obstetricians and other fetal medicine experts, voted 14-1 to withdraw Makena, citing recent study results that showed it did not prevent health problems in newborns of mothers who took the drug.
"There is no longer any evidence of effectiveness," Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, said during the panel meeting.
Covis Pharma, the manufacturer of Makena, was unsuccessful in its proposal of a trial with 400 subjects to compare the drug to a placebo.
"We believe that when a confirmatory trial fails ... that is only the beginning, not the end, of the analysis," Raghav Chari, Covis Pharma's chief innovation officer, said during the meeting.
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Covis officials also argued removing the drug would fuel racial disparities in prenatal care because it benefits pregnant people at high risk for premature birth complications, including Black Americans.
"The FDA should do what is best for our patients, which is to keep this medication available for those of us who manage these very high-risk patients every day," said Dr. Yolanda Lawson, an obstetrics specialist at Baylor University.
But FDA scientists argued they were unable to identify a group for which Makena was effective, adding the drug also carries risks for blood clots and depression.
"It is very weighty to think about the most vulnerable populations, not giving them access to a treatment that might help them," said Anjali Kaimal, a professor of obstetrics and gynecology at the University of South Florida’s Morsani College of Medicine. "But in the same conversation, to think that I’m going to give a very vulnerable population an ineffective treatment also just doesn’t seem like the right thing to do."
The panel's decision was the latest in a long effort by regulators to remove the controversial drug from the market.
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The drug received accelerated approval from the FDA in 2011, based on a study that showed it appeared to reduce premature birth rates, according to documents published by the agency. Makena was approved on the condition that a larger follow-up study would be necessary to confirm its effectiveness.
In 2019, results from that study, which included over 1,700 patients, showed the drug did not reduce premature births or lead to better health outcomes for babies.
Then, in 2020, the FDA proposed removing Makena from the market, according to a previous statement from the agency. Covis, in turn, requested a rare hearing to make its case for keeping the drug on the market.
In Wednesday's vote, the FDA advisory panel agreed with the 2020 decision.
"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," Dr. Margery Gass, an obstetrics specialist, said at Wednesday's hearing. "I think that’s a bad precedent."
The FDA commissioner is expected to make a final decision on whether to withdraw the drug in the next several months.
Contributing: The Associated Press
Contact News Now Reporter Christine Fernando at cfernando@usatoday.com or follow her on Twitter at @christinetfern.