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FDA Officially Withdraws Makena, the Only Preterm Birth Med

Article

Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”

After an FDA committee recommended withdrawing approval for Covis Pharma’s Makena (hydroxyprogesterone caproate injection), which reduces the risk of preterm birth, last October, the agency officially withdrew approval of the drug on April 6.

Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”

The FDA approved Makena under the accelerated approval pathway in 2011 to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The approval included a requirement that the sponsor conduct a post marketing confirmatory study, which “did not verify clinical benefit,” the agency said.

The FDA’s Center for Drug Evaluation and Research (CDER) proposed withdrawing the drug’s approval in 2020 and its Obstetrics, Reproductive, and Urologic Drugs Advisory Committee held a hearing on the withdrawal in October 2022.

“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 Robert M. Califf, M.D. “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.”

“After thoroughly reviewing the record for this matter, we have determined that there is an insufficient demonstration of effectiveness to balance any level of risk,” wrote Califf and FDA Chief Scientist Namandjé N. Bumpus, Ph.D. in the decision.

The agency “acknowledges at the outset the serious problems of preterm birth with respect to both maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women,” Bumpus said. “Nothing in this opinion today is intended to minimize these concerns — to the contrary, our hope is that this decision will help galvanize further research.”

“In light of this unmet need, it is imperative that the medical and scientific communities redouble their efforts to find effective treatments, including further research on Makena,” Califf and Bumpus wrote.

After the October hearing, Covis submitted a response noting that safety and efficacy data continue to support the approval of Makena, at least in a narrower indication, the manufacturer said. “Nevertheless, Covis respects the recommendations of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, and, in light of its recommendations, is seeking to voluntarily withdraw the Makena NDA.”

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