Two-and-a-half years after it first proposed doing so, the US Food and Drug Administration (FDA) has made a final decision to immediately withdraw Makena from the market, a hydroxyprogesterone caproate injection approved by the agency in 2011 to reduce the risk of 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 Robert Califf. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”
FDA’s decision comes after Makena’s manufacturer, Covis Pharma, agreed to voluntarily withdraw the drug from the market. In a press release announcing the withdrawal on 7 March 2023, the company said they continue to support Makena in a narrower indication of women at the highest risk of pre-term birth, but would “voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down.”…
