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FDA withdraws approval of Makena, the only drug approved to reduce preterm birth




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

In a statement, FDA Commissioner Robert M. Califf, who issued the decision along with the agency’s chief scientist, said it is 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 for FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have FDA-approved status.”

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

The decision, which was not a surprise, marks the culmination of a lengthy process that began in 2020 when the FDA’s Center for Medicines proposed removing the drug from the market. A month ago, Covis Pharma, the Luxembourg manufacturer of Makena, announced that it would voluntarily stop selling the drug. It followed a recommendation from the FDA’s external experts last autumn that the drug be withdrawn.

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

The FDA said some supplies of Makena have been distributed to doctors’ offices and pharmacies, and some health care providers may continue to prescribe or administer the drug. But it urged providers to “consider the FDA’s conclusion that these drugs have not been shown to be effective for the indication for which they were approved and do not have benefits that outweigh the risks to patients.”

Preterm birth, 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 early, risk lifelong complications and death. Black newborns are more than twice as likely to die as white newborns. The cause of premature birth is unknown.

The debate over the fate of Makena has in recent years developed into a complicated vortex of racial and medical considerations.

Makena, which was approved in 2011, is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. The agency approved the drug on accelerated approval because a 2003 clinical trial showed the drug reduced the risk of premature birth, suggesting it would improve the health of the baby.

The drug was approved for women who had experienced a premature singleton birth — one that does not involve twins or other multiples. The weekly treatment was started 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 necessary follow-up study showed that the drug did not benefit either mothers or babies. In October 2020, when the agency’s Drug Center proposed that Makena be removed from the market, Covis opposed the move, triggering a lengthy review made more protracted by the coronavirus pandemic.

Covis, which is owned by private equity firm Apollo Global Management, argued that scrapping the drug would harm black women and that the larger study was flawed because it did not have a significant proportion of black patients. It wanted to conduct a new trial to prove its 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, Mass., dismissed that argument as “racial entitlement spin.” In an opinion piece in Stat, an online medical publication, last September, Urato wrote: “How does keeping Makena on the market — allowing pregnant black women to be disproportionately injected with an ineffective drug — improve racial equity in any way?”

Last fall, 15 outside advisers to the FDA unanimously voted that the drug did not help mothers or babies, and all but one said it should be removed from the market. Covis then offered its “wind-up” plan. But the FDA Center for Medicines wanted an immediate withdrawal, so the case went to the FDA commissioner and the agency’s chief scientist, Namandjé Bumpus.

At the hearing of FDA advisers 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 – side effects include blood clots, allergic reactions and depression – without evidence of benefit.

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

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

The agency noted Thursday that drugs containing that ingredient can be legally compounded if certain conditions are met. But it warned healthcare professionals to be aware of the FDA’s view of Makena. The agency also noted that compounded drugs, including those containing hydroxyprogesterone caproate, do not undergo FDA prior review for safety, efficacy, or quality.

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

Ariana Eunjung Cha contributed to this report.



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