WASHINGTON, D.C. – Covis Pharma announced late Tuesday that it plans to voluntarily withdraw Makena (hydroxyprogesterone caproate) for prevention of preterm birth from the market. This action follows the nearly unanimous recommendation of the U.S. Food and Drug Administration’s (FDA) Obstetrics, Reproductive, and Urologic Drugs Advisory Committee in October 2022 that the drug be withdrawn from the market. Public Citizen petitioned the FDA in 2019 to ban the drug after a large post-approval clinical trial found that it is not effective for preventing preterm birth or major complications in newborn infants related to preterm birth. Dr. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:
“Makena should have been removed from the market soon after the results of the postmarket PROLONG trial demonstrating that the drug provided no clinical benefits were released in early 2019.
“In the absence of evidence showing that Makena was effective for reducing the risk of preterm labor, Covis Pharma’s failure to voluntarily withdraw the drug from the market until now unacceptably allowed women and their fetuses to be exposed to the known and potential serious risks of an ineffective drug.
“The years-long delay in the FDA taking action to withdraw approval of the new drug application for Makena also demonstrates fundamental deficiencies in the current regulatory oversight for drugs after approval under the accelerated approval pathway.”