Covis gets long-awaited FDA hearing date to decide fate of preterm birth drug

At long last, Covis Pharma has announced that the U.S. FDA has set a date to determine the future of the drugmaker's preterm birth prevention drug, Makena.

The agency's Obstetrics, Reproductive and Urologic Drugs Advisory Committee will meet from Oct. 17-19, 2022 to discuss the medicine with the  Luxembourg-based pharma company.

Along with its five generic versions, the Makena injection — 17 α-hydroxyprogesterone caproate — is the only FDA-approved treatment to reduce the risk of preterm birth in women with a single pregnancy who have a history of single spontaneous preterm birth.

AMAG Pharmaceuticals received accelerated approval for Makena in 2011 to reduce the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth — which is the delivery of a baby before 37 weeks. As part of this accelerated approval, the company was required to conduct a clinical trial to confirm the drug provided clinical benefit to newborns.

In Oct. 2020, Covis Group acquired AMAG Pharmaceuticals. Days later, the FDA proposed that Makena be withdrawn from the market because the required postmarket study failed to verify clinical benefit — and the agency concluded that the available evidence does not show Makena is effective for its approved use.

FDA issued a notice of opportunity for a hearing (NOOH) to AMAG/Covis as well as to all the application holders for the approved generics to Makena. Now, the date has finally been set for Covis' hearing.

According to Covis, the company is willing to launch another study to clarify the risk-benefit of the drug, and will be presenting proposed study options at the October hearing.

At this time, Makena remains approved and available, and the product label remains unchanged.