Citing Ineffectiveness, FDA Panel Recommends Taking Down Famed Preterm Birth Drug From Market

  • Federal health advisers recommended pulling Covis Pharma's preterm birth drug from the market because it has not been shown to be effective.
  • The FDA's advisory panel voted 14-1 to withdraw Makena, citing recent study results that showed it did not prevent health problems in newborns of mothers who took the drug.
  • Many of its members argued that this step is needed to allow further testing to see if this drug actually works.
  • The FDA has sought to pull the approval of hydroxyprogesterone caproate injection (Makena) since 2020 because the required postmarket study failed to verify clinical benefit. The agency also concluded that the available evidence does not show Makena is effective for its approved use.
  • Makena received accelerated approval in 2011 to reduce the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth, which is the delivery of a baby before 37 weeks.
  • The panel also noted risks associated with Makena, including thromboembolic events, allergic reactions, depression in labeling - Warnings and Precautions, and injection site reactions.
  • Murphy et al. reported increased cancer risk in the children of women treated with hydroxyprogesterone caproate, the active ingredient in Makena.
  • Apollo Global Management Inc APO acquired Covis Pharma in 2020 from Cerberus Capital Management.
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