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FDA Withdraws Pre-Term Birth Drug

Roughly 1 in 10 infants born in the U.S. are preterm, placing both the baby and mother at higher risk of death or disability.

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According to a recent CNN article, the FDA has withdrawn its approval of Makena, a drug approved over a decade ago to reduce the risk of preterm birth, which had been the only medication approved for the condition. The FDA says the drug isn’t effective, and its benefits don’t outweigh the risks. The drug disproportionately affects Black women, for whom the rate of preterm birth is about 50% higher than for White or Hispanic women. Preterm birth has also been a growing problem in the US, with the rate rising from 10.1% in 2020 to 10.5% in 2021.

Before Makena, there were no reliable medication options for patients suffering from preterm birth, so it went through the FDA’s accelerated approval process. That process is used when there’s no reliable treatment for a condition, and a drug shows promise in clinical trials. One condition of accelerated approval is that, even after the drug hits the market, the company must continue to test it in people to ensure it works. 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.

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