After a long-awaited decision on the fate of its approved preterm birth med, Covis was handed some bad news from a U.S. FDA advisory panel.
The Obstetrics, Reproductive, and Urologic Drugs Advisory Committee to the FDA voted 14-1, recommending that the FDA pursue withdrawal of approval of the drug, branded Makena. In the panel's closing summary, it did not mince words, noting that, "Makena has not been shown to be effective; substantial evidence of effectiveness is lacking" citing two different trials. Additionally, the panel pointed out that with Makena on the market, it will likely take a decade or more to complete another trial – but this can happen quicker if the drug is off the market. The panel also added that, "failure to remove Makena undermines the accelerated approval pathway."
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 Days later, the FDA proposed that Makena be withdrawn from the market because the required postmarket study failed to verify clinical benefit — and the agency concluded that the available evidence does not show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. In June 2022, the Oct. date was set for Covis' committee hearing.
In a brief media release, the Luxembourg-based company said it will work collaboratively with the FDA to clarify the next steps in this process, noting that Makena remains approved and the product label remains unchanged until the company is handed a final decision by the FDA.