FDA takes only drug for premature birth off the market

MIAMI --  On Thursday, the US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risk.

"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 Dr. Robert Califf said 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."

Effective Thursday, the agency says, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.

Last month, the maker of the drug said it was moving to withdraw the medication from the market after an FDA panel said it is not effective.

"While we stand by Makena's favorable risk-benefit profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down," Covis Pharma Chief Innovation Officer Dr. Raghav Chari said in a news release at the time.

In October, the FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large study failed to show that it was effective. It also voted that a postmarket trial didn't show any benefit to babies and that the evidence didn't show that Makena reduced the risk of preterm birth in women who had had one before.

Covis said that soon after the committee hearing, it outlined a plan for withdrawal that included a wind-down period allowing patients to finish the 21-week course of treatment. However, the FDA's Center for Drug Evaluation and Research rejected the plan.

The FDA said while the approvals of Makena and its generics have been withdrawn, the agency recognizes that there is a supply of product that has already been distributed. It said patients who have questions should talk to their health care provider.