FDA withdraws preterm-birth drug Makena and its generics from US market after 12 years

The FDA had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment appeared on the market. The drug was approved in 2011 using the agency’s accelerated-approval pathway as a treatment to reduce the risk of spontaneous preterm birth in pregnant women who had a history of the condition.

The drug was approved in 2011 using the agency’s accelerated-approval pathway as a treatment to reduce the risk of spontaneous preterm birth in pregnant women who had a history of the condition. The decision by the FDA and its chief scientist highlights a gap in treatment for some women. “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,” said FDA Commissioner Dr. Robert M. Califf in a statement.

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” he said.

The move comes after the drug failed to verify clinical benefit in a postmarketing confirmatory study that was almost four times the size of the original study, leading its sponsor, Covis Pharma, to request a hearing, which was conducted in October of 2022. The confirmatory trial found the hormone-based treatment did not prevent preterm birth or show a benefit for newborns.