The US Food and Drug Administration (FDA) advisory committee voted that a drug to reduce the risk of preterm birth should be removed from the market.
The FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 14-1 on Wednesday to recommend withdrawing Makena from the market until the appropriate confirmatory study is conducted.
According to the committee, the post-market study failed to prove the efficacy of Makena (17α-hydroxyprogesterone caproate), the only approved drug to prevent preterm birth in the US.
Makena was approved in 2011 based on the results of the Meis trial, which demonstrated a 42% reduction in the rate of recurrent preterm birth before 35 weeks of gestational age in women with a history of spontaneous preterm labor.
However, the findings of the Meis trial were criticized because the rate of preterm birth in the placebo group was higher than projected.
The FDA approved Makena on a condition to conduct a second confirmatory study, known as PROLONG (Progestin's Role in Optimizing Neonatal Gestation).
The trial, which was initiated by the previous Makena's sponsor AMAG, later acquired by Covis Pharma, showed that there were no significant differences in the frequency of preterm births before 35 weeks or neonatal morbidity index, as well as fetal/early infant death between the group taking Makena and the placebo group.
In September, Covis Pharma said that the PROLONG trial, primarily carried out outside the US, included significantly fewer Black women who are most at risk of preterm labor compared to the Meis trial, 6.7% and 59%, respectively.
"Withdrawal of accelerated approval for Makena and its generic equivalents would have significant negative public health consequences for high-risk pregnant women, including Black and minority women and socially-disadvantaged populations," Covis said.