In a rare move, an advisory FDA panel voted 14-1 Oct. 19 in support of retracting Makena, the only treatment approved to help prevent preterm birth, from the market, which the agency fast-tracked and approved in 2011.
For two and a half days, the committee discussed the efficacy of Makena, which was approved based on a 2003 trial that involved about 400 women. A follow-up trial of more than 1,000 women, which was conducted in 2019 and published results in 2020, found the drug did not reduce the risk of a preterm birth.
In the panel's first voting question, "Do the findings from Trial 003 verify the clinical benefit of Makena on neonatal morbidity and mortality from complications of preterm birth?" all 15 voted no.
In the U.S., 1 in 10 infants are born early, which is defined as birth before 37 weeks in the gestation period. Preterm birth and low birth weight babies are responsible for about 17 percent of deaths in the child's first year, according to the CDC.
Preterm births disproportionately affect Black populations compared to white and Hispanic populations. In the confirmatory trial that showed Makena did not work, 87 percent of the participants were white.
"Keeping Makena on the market does nothing to help racial equity — it just puts Black moms & their babies at risk," Massachusetts obstetrician-gynecologist Adam Urato, MD, tweeted Sept. 26. "FDA: Ignore a pharma company's deceptive racial equity argument for Makena."
Because the treatment is the only FDA-approved drug for preterm births, Makena's drugmaker, Covis Pharma, has previously argued there needs to be another trial to act as a tiebreaker between the two trials.
In response to the panel's vote, Covis Pharma said in a statement that the company thinks Makena is effective.
"We're back to square zero," one of the panel members said during the third day of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee meeting.
The FDA does not always follow advisory panel votes, but usually does.