Makena, the only drug approved to prevent premature births, has not shown to be effective and exposes women to “serious risk,” the agency’s scientists said.
An advisory panel to the Food and Drug Administration voted Wednesday to take a drug intended to prevent premature births off the market, saying that it remains doubtful that the drug works.
The recommendation, in a 14-1 vote, from the agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee closed a three-day meeting on the clinical trial evidence supporting Makena, the only drug approved in the U.S. to prevent preterm births.
The meeting included emotional testimony, including from advocates who said removing the drug could deepen maternal health inequities.
The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The panel voted no on each question.
“It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy,” said panel member Dr. Mark Hudak, a pediatrician at the University of Florida College of Medicine in Jacksonville.
Preterm birth is when a baby is born before 37 weeks, and occurs in about 1 in 10 births in the U.S., according to the Centers for Disease Control and Prevention. Black women in the U.S. are at higher risk for the complication, which can cause chronic health problems for babies throughout their lives.
Makena is a synthetic hormone administered weekly, usually beginning at 16 weeks of pregnancy.
Wednesday’s recommendation is largely based on 2019 clinical trial data of more than 1,500 women who received a weekly injection of Makena, beginning at 16 weeks of pregnancy, or a placebo. The trial found that the drug failed to reduce the risk of preterm births or produce better health outcomes for newborns.
The panel’s vote doesn’t mean the drug will be removed from the market; that decision is left to the FDA, which could make its final decision within a few months.
The agency, however, has already proposed revoking the drug’s approval once before.
