The Food and Drug Administration on Thursday revoked the approval of Makena, the latest — and probably last — chapter of a long-running saga involving the only drug cleared to reduce the risk of preterm birth.
Covis, which is owned by private equity firm Apollo Global Management, argued that yanking the drug would hurt Black women, and that the larger trial was flawed because it did not have a significant proportion of Black patients. It wanted to conduct another trial to prove its point. Some Black health groups also supported keeping the drug on the market.
Last fall, 15 outside advisers to the FDA voted unanimously 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-down” plan. But the FDA drug center wanted an immediate withdrawal, so the issue went to the FDA commissioner and the agency’s chief scientist, Namandjé Bumpus.
Before Makena was approved, pharmacists sometimes made their own versions by compounding drugs that included the active ingredient, hydroxyprogesterone caproate.
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