Makena, the only drug that the Food and Drug Administration has approved to prevent preterm births, will be pulled from the market, drugmaker Covis said Tuesday.
with the FDA that the 2019 study was flawed. They noted the study had a significantly lower percentage of
Black patients and that the subjects had lower health risks compared to the previous, smaller study. This “left the study not appropriately powered to demonstrate efficacy,” Covis wrote. Adams Waldorf said she was not convinced by the argument that Makena might be effective for a portion of the population. “As soon as you have something in science that’s very difficult to replicate, it should engender a lot of suspicion in all of us,” she said. “I understand the hope that maybe it works for a subset of a subset of the population. But in no way is that good enough for the most important problem in obstetrics to date.
But Larry Rand, an OB/GYN and director of perinatal services at the University of California San Francisco Fetal Treatment Center, said that the “available evidence” suggests that Makena could make a difference in reducing preterm births among Black women.
The NAACP had expressed concern that pulling the drug would “deepen profound existing maternal and infant health inequities in the U.S.,”Ariana Eunjung Cha contributed to this report.
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