A panel of experts that advise the U.S. Food and Drug Administration recommended Wednesday that the agency stop allowing the sale of a hormone injection meant to stave off premature births, because they say it doesn’t work and carries some risks of other health issues.
The drug, Makena, was approved under the agency’s accelerated approval program in 2011. The program allows drugs to be sold before clinical trials showing their benefits are completed.
Prior to Makena’s approval, studies had shown a 30% decrease in preterm births. A larger study in 2019 showed that the drug was no more effective than a placebo. A preterm birth is when a baby is born before 37 weeks of pregnancy have been completed.
According to the Centers for Disease Control and Prevention, in 2020, one of every 10 infants born in the United States was born before 37 weeks of pregnancy.
While the company that makes Makena, Covis Pharma, has argued to keep selling the drug, the panel voted 14-1 to recommend revoking its approval.
Covis argued that despite some risks, the drug would be of specific value to Black and minority communities which have higher preterm delivery rates.
The withdrawal of accelerated approval “would have significant negative public health consequences for high-risk pregnant women, including Black and minority women and socially disadvantaged populations,” the company said.
Dr. Peter Stein, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, said Wednesday that it was in the best interest of patients for Makena to be removed from the market.
“We heard from many clinicians and patients over the past days, and we heard them very clearly: They want an effective drug on the market and can accept some uncertainty,” Stein said.