The FDA withdrew its approval of Makena, the only preterm birth drug greenlit by the agency, on April 6 after research showed the treatment did not work better than a placebo.
The repealed approval follows an FDA advisory panel voting in favor of removing Makena and the drugmaker announcing it would halt sales.
Makena, made by Switzerland-based Covis Pharma, achieved fast-track approval and entered the market in 2011 based on a trial of about 400 women. A follow-up study conducted in 2019 that included more than 1,000 women found the drug did not reduce the risk of a preterm birth. The conflicting results stirred controversy and the eventual reversal of approval.
"It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes — particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women," FDA Commissioner Robert Califf, MD, said in a statement.
"Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment," Dr. Califf said. "Without that favorable assessment, the drug should not have the status of being FDA-approved."
In the U.S., 1 in 10 infants are born before 37 weeks in the gestation period. These preterm births, plus babies with low weights, are responsible for about 17 percent of deaths in the child's first year, according to the CDC.