On Thursday, The U.S. Food and Drug Administration (FDA) announced its final decision to withdraw the approval of Makena, a drug that was granted approval through the accelerated approval pathway.
Makena was originally approved to decrease the risk of preterm birth in pregnant women with a history of spontaneous preterm birth who are carrying a single baby. As of today, the drug and its generic versions are no longer approved and cannot be distributed in interstate commerce in accordance with the decision.
“The fact that no treatment has been proven effective in preventing preterm birth and improving neonatal outcomes, especially in communities of color where this condition has a disparate impact, is tragic,” said Dr. Robert M. Califf, FDA Commissioner. “However, the primary consideration for FDA drug approval is a positive benefit-risk assessment. If the assessment is not favorable, the drug should not be approved by the FDA.”
In 2011, the FDA granted approval of Makena under the accelerated approval pathway after the sponsor demonstrated a drug effect on an intermediate clinical endpoint that was likely to predict clinical benefit. However, the approval was contingent upon the sponsor conducting a post-marketing confirmatory study. When the confirmatory study failed to demonstrate clinical benefit, the FDA’s Center for Drug Evaluation and Research (CDER) recommended withdrawing the drug’s approval in 2020. Following the sponsor’s request for a hearing, a hearing was held in October 2022.
After a review of the matter, including the submissions made by Covis Pharma, the Center for Drug Evaluation and Research, public comments, and the hearing transcript and report, the FDA Commissioner and Chief Scientist have decided to withdraw the approval of Makena and its generic versions.
The decision put forth today by the FDA Commissioner and Chief Scientist provides an explanation for their decision and acknowledges the critical necessity of creating therapies to alleviate the severe hazards linked with premature birth.
“We recognize the significant health issues associated with preterm birth for both mothers and neonates, as well as the institutional factors that have led to health inequalities, including preterm birth, among Black women,” stated Namandjé Bumpus, Ph.D., the FDA’s Chief Scientist. “Our decision today does not intend to downplay these concerns. On the contrary, we hope that this action will spur additional research.”
Although Makena and its generics are no longer approved by the FDA, there is a supply of the product that has already been distributed. The FDA advises patients who have concerns to consult with their healthcare provider. The decision to withdraw approval of these drugs was made because they are no longer proven to be effective, and the risks outweigh the benefits for the indication for which they were approved. For more information, please refer to the Makena Information on FDA.gov.
Source: FDA