April 7, 2023
Life Sciences | Tea Leaves
  • On Thursday, the U.S. Food and Drug Administration (FDA) announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth that had been the only medication approved for the condition. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risks. Makena was approved in 2011 for women with a history of spontaneous preterm delivery after a clinical trial showed a reduction in the rate of preterm births but no direct clinical benefit. In the years since Makena was approved, drugmaker Covis says, about 350,000 women have been treated with it, but a large 2019 study failed to show that it actually prevented preterm birth. (Articles here, here, and here)