FDA Sets Hearing Date for Covis' Beleaguered Preterm Birth Drug


On Tuesday, Covis Pharma GmbH announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial pre-term birth prevention drug Makena (hydroxyprogesterone caproate injection). Makena was previously marketed by AMAG Pharmaceuticals, which was acquired by Covis in October 2020.

Makena is an injectable progestin treatment to reduce preterm births, or, births that occur before 37 weeks of pregnancy have been completed. Preventing preterm births is extremely important because babies that are born prematurely can develop health problems including respiratory distress syndrome, neonatal sepsis and intraventricular hemorrhage. The Centers for Disease Control and Prevention states that in 2020, one in ten babies were born too early in the U.S.  

Makena was granted accelerated approval in 2011 by the FDA based on results from a single clinical trial which showed that it produced a 42% reduction in the rate of recurrent preterm birth, making it the only drug available to prevent preterm birth. However, as with all accelerated approvals, the FDA reserved the right to withdraw the approval of the drug if future confirmatory trials fail to demonstrate clinical benefit.

This was exactly the case in October 2020 when the FDA proposed the withdrawal of approval from Makena. The decision came after reviewing data collected by Covis over a period of nine years which failed to verify the drug’s clinical benefit. The FDA’s Center for Drug Evaluation and Research stated that the available evidence did not show that Makena was effective in its approved use of reducing preterm births. Additionally, the agency determined that the confirmatory trial failed to show Makena was effective for improving the health of babies born to those with a history of unexplained preterm birth.

AMAG and Covis disagreed with the decision and chose to request an oral hearing from the agency. In August 2021, the FDA announced that a public hearing would be held to address the agency’s decision.

Now, nearly a year later, the FDA has provided Covis with an official date for its hearing. The regulator anticipates holding a meeting of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on October 17-19 this year. Currently, Makena is still approved by the FDA and remains available on the market with the FDA’s final decision on the drug to be made following the October hearing.

“Covis is committed to working with the FDA to conduct additional research to explore and document the benefits of Makena. We are committed to further study to clarify the risk-benefit of this drug, given the inconsistent efficacy outcomes between the landmark Meis study and PROLONG, and the important role Makena plays in this high-risk and underserved patient population,” Covis CEO Michael Porter said in a press release. “This need for further study is underscored by the very fact that there are no approved alternatives available for high-risk patients – who for over a decade have been relying on this product and its generic versions to help carry their babies to term.”

To that end, Covis has been working on a path forward to conduct additional research to explore the efficacy of Makena which it will present at the meeting.

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