Press Release

Covis Pharma Provides Update on FDA Public Hearing for Makena®

Zug, Switzerland, June 14, 2022 – Covis Pharma GmbH, an affiliate of Group S.à r.l. (collectively, “Covis”), announced today that the U.S. Food & Drug Administration (FDA) anticipates holding a meeting of the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) on October 17-19, 2022, to conduct a hearing about the future of Makena® (hydroxyprogesterone caproate injection). More information about the structure of the hearing can be found here. Prior to the hearing, FDA will publish a notice in the Federal Register that provides details on how to submit a request to FDA to participate in the hearing.

FDA’s announcement of the anticipated hearing date is the latest development following FDA’s August 2021 order granting a hearing on its proposal to withdraw approval of Makena and its five generic versions. Covis requested that hearing in 2020, after FDA proposed to withdraw approval and issued a Notice of Opportunity for a Hearing (NOOH). FDA proposed to withdraw Makena’s approval following a 2019 Advisory Committee split vote (9-7) after a review of the PROLONG trial results, which did not confirm the benefit of 17-OHPC in a different population of women than those studied in the approval trial (Meis et al).

Along with its five generic versions, Makena, also referred to as 17 α-hydroxyprogesterone caproate, 17-OHPC, 17-HPC, or 17P, is the only FDA-approved treatment to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

FDA’s final decision will be made following the October 2022 hearing. Covis continues to welcome the opportunity to discuss a data-driven path forward to address the conflicting efficacy results between two clinical studies on Makena, including the completed confirmatory study.

“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,” said Covis CEO Michael Porter. “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.”

Covis has urged FDA to allow the company to do additional research to fully explore the efficacy of Makena for indicated patients and looks forward to presenting proposed study options at the October hearing.

In this context, Covis is working diligently with experts to develop feasible and timely options that improve upon the previous sponsor’s proposal for additional studies. Specifically, Covis is exploring two alternative options: (1) conducting a prospective historical control study, consistent with FDA guidance, and/or (2) conducting a randomized clinical trial (RCT) relying on an analysis of retrospective datasets for the purpose of identifying relevant subgroups for study. Covis is currently conducting feasibility analyses and will follow the emerging data on the appropriate study option. The company proposes to undertake an appropriate study while ensuring that approved therapeutic options remain available.

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

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About Covis
Covis, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at​ www.covispharma.com.

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