The FDA only withdraws drugs for premature births from the market

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

“It is tragic that the scientific research and medical communities have yet to find an effective treatment to prevent preterm birth and improve neonatal outcomes – especially considering that this serious condition has a disparate impact on communities in color, especially black women,” FDA Commissioner Dr. Robert Califf said in a statement. “Fundamentally, however, the touchstone of FDA drug approval is a favorable assessment of the benefits and risks; without this favorable evaluation, the drug should not have the status of being approved by the FDA.

As of Thursday, according to the agency, Makena and its generics are no longer approved and cannot legally be distributed in interstate commerce.

Last month, the drugmaker said it was considering pulling the drug from the market after an FDA panel said it was not effective.

“While we stand by Makena’s favorable risk-benefit profile, including its effectiveness in women most at risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effect an orderly liquidation. “said Covis Pharma’s chief innovation officer. Officer Dr Raghav Chari said in a press release at the time.

In October, the FDA’s Obstetric, Reproductive, and Urology Drug Advisory Committee voted to keep Makena off the market after a large study failed to show it worked. It also voted that a post-marketing trial showed no benefit for babies and that the evidence did not show Makena reduced the risk of preterm birth in women who had had one before.

Covis said shortly after the committee hearing, it presented a withdrawal plan that included a cool-down period allowing patients to complete the 21-week treatment. However, the FDA’s Center for Drug Evaluation and Research rejected the plan.

The FDA said that although approvals for Makena and its generics have been withdrawn, the agency recognizes that there is product supply that has already been distributed. He said patients who have questions should speak to their healthcare provider.