FDA Withdraws Approval Of Makena On Lack Of Favorable Benefit-risk Assessment

(RTTNews) - The FDA has announced Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. The drug that had been approved under the accelerated approval pathway was used to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth.

In 2011, the FDA approved Makena under the accelerated approval pathway based on a determination that the sponsor had showed a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. However, the ensuing confirmatory study did not verify clinical benefit. A sponsor-requested hearing was held in October 2022. Based on a review by the Commissioner and Chief Scientist, FDA has decided to withdraw approval of Makena and generic versions of Makena.

FDA Commissioner Robert Califf, stated: "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 marketed by AMAG Pharmaceuticals, Inc., which is now a subsidiary of the Covis Pharma Group.

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