Covis, the manufacturer of the controversial preterm birth prevention drug Makena, has announced it will voluntarily withdraw the drug from the market after recommendations from the Center for Drug Evaluation and Research.
Makena (Hydroxyprogesterone caproate, Covis Pharma Group) will be withdrawn from the market voluntarily by Covis.1
Currently, Makena is the only treatment for reducing the risk of preterm birth approved by the FDA for use in women who experienced a spontaneous preterm birth in the past.
Recommendations from the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee have led Covis to voluntarily withdraw the NewDrug Applicationfor Makena. A plan was outlined by Covis for withdrawing the preterm birth prevention drug without the need for future proceedings.
A wind-down period to give patients the opportunity to finish their 21-week treatment was included in the plan Coviscreated but was not agreed upon by the Center for Drug Evaluation and Research, who requested proceedings continue until the FDA commissioner and chief scientist make a decision.
An FDA advisory committee voted to have hydroxyprogesterone caproate withdrawn from the market in October 2022,2 though Covis appealed the decision at the time. In a rare public hearing, Covis was urged by panelists to further research the drug for efficacy data in a subgroup of women.
While Makena received accelerated approval in 2011, a 2019 study showed insufficient efficacy results. This led the FDA to call for the drug’s removal in 2020.
As significant safety concerns have not been found from hydroxyprogesterone caproate at this time, Covis has requested a date be set for wind-down to allow patients not to be disrupted in the middle of their treatment.1 Currently, the product label for Makena has not been changed, and the product remains approved.
“We recognize the attention the agency has directed to this issue, particularly given the complexity around withdrawing a drug with mixed efficacy data and a positive safety profile, and welcome the opportunity to discuss an appropriate wind-down plan for patients,” said Raghav Chari, PhD, chief innovation officer at Covis.
1. Covis Pharma responds to presidingofficer’s report summarizing FDA advisory committee hearing. Covis Pharma. March 7, 2023. Accessed March 9, 2023. https://covispharma.com/index.php/covis-pharma-responds-to-presiding-officers-report-summarizing-fda-advisory-committee-hearing/
2. FDA panel backs removal of unproven pregnancy drug. Yahoo! News. October 19, 2022. Accessed March 9, 2023. https://news.yahoo.com/fda-panel-backs-removal-unproven-150245703.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuY29udGVtcG9yYXJ5b2JneW4ubmV0Lw&guce_referrer_sig=AQAAACTQ-b7A4VNPQsQ-MLa4T47Kl7lgp1cs6lz734TVKv5tjwanFEqTmjayXOBArHUzEhMV_a6mZXbo0SV7x5k-CCcLoDlcFOgcbnCZFXxeibaZELpgkT5xCMTrnxVEWGcEtsyi11VZylNb2rXO1MB1bmQLr5hZmJxOqmG6XOqPu60G