Zug, Switzerland, August 19, 2021 – Covis Group S.à r.l. (“Covis”) announced today that the U.S. Food and Drug Administration (FDA) has granted a public hearing to discuss Makena, the only FDA-approved treatment, along with its equivalent generics, to reduce preterm birth in indicated patients. The hearing follows Covis’ October 2020 formal request for a public hearing in response to the FDA’s Notice of Opportunity for a Hearing (NOOH) regarding the Agency’s proposal to withdraw approval of Makena in all its forms.
“We are grateful that the FDA responded to our request and has decided to grant a hearing to discuss Makena,” said Covis CEO Michael Porter. “Preterm birth remains an urgent public health issue in our country, particularly among minority groups. We believe that Makena is an important treatment option and we appreciate the opportunity for healthcare providers and patient populations at greatest risk to share their perspectives with the FDA as it considers the future of Makena.”
Along with its generic equivalents, Makena, also referred to as 17 α-Hydroxyprogesterone Caproate, 17-OHPC, 17-HPC, or 17P, was approved in 2011 and is the only FDA-approved medication to reduce preterm birth in women with a singleton pregnancy who have a history of spontaneous preterm birth. Makena’s approval was based on a landmark clinical trial of U.S. women with a history of spontaneous preterm birth which demonstrated that Makena reduced the rate of preterm birth rates by one-third, compared to placebo treatment. FDA’s NOOH followed the results of a confirmatory study involving primarily non-U.S. patients and a divided Advisory Committee vote.
At this time, Makena remains approved and available, and the product label remains unchanged.
Covis, with global operations in Zug, Switzerland, 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.