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The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.
FDA announced the final decision to withdraw approval of Makena on April 11, 2023. Makena is a drug that had been approved under the accelerated approval pathway to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth.
The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11. Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.
“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 M. Califf, MD, in a press release. “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.”
Makena was approved under the accelerated approval pathway in 2011 based on a purpose that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was estimated to predict clinical benefit. The decision issued by the FDA Commissioner and Chief Scientist highlights the reasoning behind it and emphasizes the need to develop treatments to reduce the serious risks associated with preterm birth.
“We acknowledge at the outset the serious problems of preterm birth with respect to both maternal and neonatal health and the contribution of institutional forces that have led to health disparities, including preterm birth, among Black women,” said FDA Chief Scientist Namandjé Bumpus, PhD, in a press release. “Nothing in this opinion today is intended to minimize these concerns—to the contrary, our hope is that this decision will help galvanize further research.”