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The FDA withdraws the approval of Makena, the only drug authorized to reduce premature births ft


The Food and Drug Administration on Thursday revoked the approval of Makena, the latest chapter, and likely the last, in a long-running saga involving the only drug approved to reduce the risk of preterm birth.

In a statement, FDA Commissioner Robert M. Califf, who issued The decision, along with the agency’s chief scientist, said it was tragic that there are no effective treatments for preterm birth, a serious condition that disproportionately affects black women and women of color. But he added: “The touchstone of FDA drug approval is a favorable assessment of benefit and risk; Without that favorable review, the drug should not have FDA-approved status.”

Simply put, the FDA believes that there is no evidence that the drug works. Approvals for generic versions of Makena were also revoked.

The decision, which came as no surprise, marks the culmination of a lengthy process that began in 2020 when the FDA’s drug center proposed withdraw the drug from the market. A month ago, Covis Pharma, the Luxembourg manufacturer of Makena, announced that it voluntarily stop selling the drug. That followed a recommendation by the FDA’s outside experts last fall that the drug be withdrawn.

But the company was hoping for what it called an “orderly reduction” that would allow patients to complete their 21-week treatment cycles and the company to deplete its remaining inventory. Thursday’s FDA action, effective immediately, means Makena and its generic versions “are no longer approved and cannot be legally distributed in interstate commerce,” the agency said.

fda saying some Makena supplies have been distributed to doctors’ offices and pharmacies, and that some healthcare providers may continue to prescribe or dispense the medication. But he urged providers to “consider the FDA’s conclusion that these pharmaceuticals have not been shown to be effective for their approved indication and do not have benefits that outweigh the risks to patients.”

Preterm labor, which is birth before the 37th week of pregnancy, is a heartbreaking and costly health problem in the United States. About 1 in 10 babies arrive too soon, with the risk of lifelong complications and death. Black newborns are more than twice as likely to die as white newborns. The cause of preterm labor is unknown.

The debate over Makena’s fate has become a complicated whirlwind of racial and medical considerations in recent years.

Makena, which was approved in 2011, is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. The agency licensed the drug for expedited approval Because a 2003 clinical trial showed that the drug reduced the risk of preterm birth, suggesting that it would improve the baby’s health.

The drug was approved for women who have had a single preterm birth, one that does not involve twins, or multiple others. Weekly treatment began between weeks 16 and 20 of pregnancy and continued until week 37 or delivery, whichever came first. according to the label.

But in 2019, a mandatory follow-up trial showed that the drug did not benefit mothers or babies. In October 2020, when the agency’s drug center proposed Before Makena was pulled from the market, Covis opposed the move, triggering a lengthy review that was dragged on even longer due to the coronavirus pandemic.

Covis, which is owned by private equity firm Apollo Global Management, argued that withdrawing the drug would harm black women and that the largest trial failed because it did not have a significant proportion of black patients. She wanted to hold another trial to prove her point. Some black health groups also supported keeping the drug on the market.

But critics of the drug, including Adam C. Urato, a maternal-fetal medicine specialist in Framingham, Massachusetts, dismissed that argument as a “racial equity spin.” in an opinion article Writing in Stat, an online medical journal, last September, Urato wrote: “How does keeping Makena on the market so pregnant black women can get a disproportionate injection of an ineffective drug improves racial equity in some way? manner?”

Last fall, 15 external FDA advisers voted unanimously that the drug did not help mothers or babies, and all but one said it should be withdrawn from the market. Covis then offered its “downsizing” plan. But the FDA’s drug center wanted an immediate recall, so the matter was turned over to FDA commissioner and the agency’s chief scientist, Namandjé Bumpus.

At the FDA counselors’ hearing last fall, Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research, said that allowing the drug to remain on the market would expose pregnant women to serious risks: the side effects Side effects include blood clots, allergic reactions, and depression, with no evidence of benefit.

Covis did not immediately respond to a request for comment. The company, in a letter to Califf last month, said it “continues to believe in Makena’s favorable risk-benefit profile, including its efficacy in women at increased risk of preterm birth.”

Before Makena was approved, pharmacists sometimes made their own versions by combining drugs that included the active ingredient, hydroxyprogesterone caproate.

The agency noted Thursday that drugs containing that ingredient can be legally combined if certain conditions are met. But he cautioned health care providers to be aware of the FDA’s views on Makena. The agency also noted that compounded drugs, including those containing hydroxyprogesterone caproate, do not undergo FDA premarket review for safety, efficacy, or quality.

Makena is often held up as an example of failures in the FDA’s expedited approval process. The required confirmatory trial should not have taken eight years to complete, critics say.

Ariana Eunjung Cha contributed to this report.



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