Regulator Orders Drugmakers to Halt Premature Birth Drug After Decade of Sales Despite Doubts About Effectiveness

FDA withdraws approval for Makena, the only drug approved to prevent premature births, citing lack of evidence it worked.
Makena has generated billions in sales over 10+ years despite doubts about its effectiveness, highlighting flaws in the FDA's accelerated drug approval process.
The FDA's decision leaves at-risk pregnant women without any approved treatment options to prevent preterm births, which disproportionately impact women of color.
Swiss drugmaker Covis Pharma pushed to keep Makena on the market for several more months but the FDA rejected their proposal citing the drug's ineffectiveness.