FDA Advisers Back Withdrawing Covis’ Preterm Birth Drug (2)

Covis Pharma’s preterm birth drug should be removed from the market, a panel of outside advisers to the FDA said Wednesday, citing a lack of evidence defending the drug’s clinical benefit since its approval more than a decade ago.

If the agency agrees with the advisers’ recommendation, it would mark the first withdrawal of an accelerated drug approval in more than 10 years.

The Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 14-1 to back withdrawing Makena, which the Food and Drug Administration approved through its accelerated pathway in 2011 to reduce the risk of preterm birth among patients who ...