The U.S. Food and Drug Administration said Thursday it has reached a final decision to fully withdraw approval of pre-term birth drug Makena and its generics, a full 12 years after it hit the market. The drug was approved using the agency’s accelerate approval pathway in 2011 as a way to reduce the risk of pre-term birth in women pregnant with one baby who had a history of spontaneous pre-term birth. “It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” said FDA Commissioner, Dr. Robert M. Califf, in a statement. The move comes after the drug failed to verify clinical benefit in post marketing confirmatory study, leading its sponsor, Covis Pharma, to request a hearing, which was conducted in October of 2022. Luxembourg-based Covis acquired Makena as part of its takeover of Amag Pharmaceuticals in 2020.
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