FDA to pull preterm birth drug Makena from the market

After an advisory panel to the ​​Food and Drug Administration (FDA) concluded that Makena, a progesterone injection and the only drug approved to prevent preterm birth, was ineffective, drugmaker Covis announced they would be voluntarily pulling Makena from the market after 12 years. 

Makena was originally approved in 2011 as part of the FDA’s often-criticized accelerated drug approval program, which greenlights drugs for approval if early studies suggest efficacy. A small 2003 study found a 33% efficacy rate at preventing preterm birth. But that efficacy needed to be confirmed in a follow-up study, and in Makena’s case, a larger 2020 clinical trial found that the drug failed to prevent preterm birth—only providing false hope to pregnant patients. 

Related: Preterm birth linked to chemicals found in the vagina, study suggests

Covis has argued that the 2020 study was flawed, stating that the study was conducted in a much lower-risk population than in the smaller 2003 trial. This “left the study not appropriately powered to demonstrate efficacy,” Covis wrote.

The drug itself is considered to be very safe, with low risk to pregnant women. “While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the F.D.A. to effectuate an orderly wind-down,” said Raghav Chari, chief innovation officer at Covis, in a statement. 

Rates of preterm birth are increasing

Approximately 1 in 10 births in the U.S. are considered preterm, which is defined as occurring before week 37 of pregnancy. According to March of Dimes, the rate of preterm births is increasing—having reached a 15-year high in 2021—and the risk disproportionately affects Black and Native American women, who are 62% more likely to have a preterm birth than white women. 

Babies who are born preterm are more likely to have both short-term and long-term health consequences such as vision and hearing problems, asthma or developmental delays. Premature infants also are at higher risk of sudden infant death syndrome (SIDS). 

Pulling Makena from the market means that pregnant people with a history of preterm birth will now have even fewer options at hand to prevent future preterm birth, a condition we still know very little about. 

Related: WHO now recommends all preterm babies receive immediate skin-to-skin contact after birth

Injectable progesterone may still be available from compounding pharmacies, but the latest research showing no benefit may mean doctors are less likely to prescribe it. 

According to Covis, around 350,000 women have used Makena in the past decade. If you have been prescribed Makena in the past, there’s no need to worry—the drug’s removal is based only on efficacy, not safety concerns. 

Furthering maternal health disparities

The N.A.A.C.P. has argued that pulling the drug will continue to further the disparity in maternal health outcomes. While some still feel that the drug could make a difference in higher risk Black populations, others point out that the evidence just doesn’t support its use. 

“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,” said Kristina Adams Waldorf, MD, an OB/GYN and professor at the University of Washington, to The Washington Post. “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.”