Makena, the only drug that the Food and Drug Administration has approved to prevent preterm births, will be pulled from the market, drugmaker Covis said Tuesday. The decision comes after an expert FDA panel voted to recommend withdrawing the treatment last fall, citing a major 2019 study which found no evidence the drug works.
The planned withdrawal is the latest development in a years-long controversy at the intersection of racial health disparities, pharmaceutical profits and science. About 1 in 10 U.S. births are preterm — occurring before 37 weeks — with Black and Native American women about 62 percent more likely to experience them than White women, according to maternal health nonprofit March of Dimes. Such births are associated with adverse consequences including vision and hearing problems, asthma and sudden infant death syndrome.
Some Black health groups had advocated for keeping Makena — which went through an accelerated FDA approval process after a promising early, smaller-scale trial — on the market. The debate has left doctors divided on whether to continue prescribing the treatment and sparked several days of hearings at the FDA last fall.
Raghav Chari, a top health executive at Covis, said the company continues to “stand by” what he described as Makena’s “favorable benefit-risk profile.” But they chose to voluntarily withdraw the drug “particularly given the complexity around withdrawing a drug with mixed efficacy data and a positive safety profile,” he said in a statement. Covis suggests that people who are on the treatment complete the course of injections, which can last up to 21 weeks.
Since Makena was approved 12 years ago, an estimated 350,000 people have taken the progesterone injection, which is intended for those who have previously had spontaneous singleton preterm births. The progesterone hormone keeps the uterus “quiet and happy,” said Kristina Adams Waldorf, an OB/GYN and professor at the University of Washington, who supports the withdrawal. It was originally thought “by giving additional progesterone, it will prevent contractions from prematurely starting before the due date,” she said, but those mechanisms are not completely understood.
The treatment was introduced in 2011, but a later confirmatory trial published in 2019 — in which 1,130 women received Makena and 578 received a placebo — found that the drug did not prevent preterm births. In October 2020, the FDA’s Center for Drug Evaluation and Research proposed taking it off the market because it “failed to verify clinical benefit.”
Covis argued in an 2022 filing with the FDA that the 2019 study was flawed. They noted the study had a significantly lower percentage of Black patients and that the subjects had lower health risks compared to the previous, smaller study. This “left the study not appropriately powered to demonstrate efficacy,” Covis wrote.
Adams Waldorf said she was not convinced by the argument that Makena might be effective for a portion of the population. “As soon as you have something in science that’s very difficult to replicate, it should engender a lot of suspicion in all of us,” she said. “I understand the hope that maybe it works for a subset of a subset of the population. But in no way is that good enough for the most important problem in obstetrics to date.”
But Larry Rand, an OB/GYN and director of perinatal services at the University of California San Francisco Fetal Treatment Center, said that the “available evidence” suggests that Makena could make a difference in reducing preterm births among Black women.
He wrote in a email Wednesday that the conflicting trial data considered by the FDA might not be “comparable enough to draw definitive conclusions about Makena’s effectiveness” and that pulling the drug would make treatment “much harder” and “potentially take us back to the days when we had to turn to compounding pharmacies to make the drug.”
The NAACP had expressed concern that pulling the drug would “deepen profound existing maternal and infant health inequities in the U.S.,” The Washington Post reported. The organization didn’t return a request for comment late Tuesday.
Ariana Eunjung Cha contributed to this report.
