Covis Pharma Reports on FDA Advisory Committee Hearing for Makena®
Zug, Switzerland, 19 October 2022 – Covis Pharma Group (the “Company”), today reported that the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the FDA pursue withdrawal of approval of Makena® (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.
“Covis respects the regulatory decision-making process and appreciated the opportunity to present our patient-focused study designs and data to the Center for Drug Evaluation and Research (CDER) at FDA and members of the Advisory Committee,” said Covis CEO Michael Porter. “We are also thankful for the viewpoints expressed by patients and organizations that see the importance of Makena and its generics.”
“As presented during the hearing, we believe that Makena is effective in a higher-risk patient population,” said Raghav Chari, PhD, chief innovation officer at Covis. “We will work collaboratively with the FDA to clarify the next steps in this process.”
Per the regulatory process, Makena remains approved and the product label remains unchanged at this time as the Company awaits a final decision by the FDA.
About Covis Pharma
Covis Pharma, 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.