Makena's accelerated approval withdrawal hearing set for October as Covis wants to do more research
The long-awaited FDA hearing to review Covis Pharma’s accelerated approval for its controversial preterm birth injection, which failed its confirmatory trial, will take place from Oct. 17-19.
The FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee will conduct the hearing about the future of Makena (hydroxyprogesterone caproate injection), the company said in a statement yesterday.
In a show of fairness, the hearing will allow for both Covis and FDA’s Center for Drug Evaluation and Research to each make two-hour presentations, and both CDER and Covis will be given a full hour to ask questions after the opposing side makes its presentation. An additional four hours will be set aside for public comments, which will allow for the generic manufacturers of Makena to also speak.
The FDA’s Celia Witten, who’s presiding over the hearing, previously told Covis that the design of any future confirmatory trial(s) is not an issue to be decided as part of this hearing process.
Even still, Covis said in a statement that it has urged FDA to allow the company to do additional research to fully explore the efficacy of Makena for indicated patients, “and looks forward to presenting proposed study options at the October hearing.”
The company said it’s developing:
Options that improve upon the previous sponsor’s proposal for additional studies. Specifically, Covis is exploring two alternative options: (1) conducting a prospective historical control study, consistent with FDA guidance, and/or (2) conducting a randomized clinical trial (RCT) relying on an analysis of retrospective datasets for the purpose of identifying relevant subgroups for study.
But some physicians are questioning the need to keep Makena on the market as these additional studies are ongoing.
“If the drug stays on the market, pregnant women across the US will continue to be injected with a synthetic hormone that has no proven benefit and possible short and long-term harms,” Adam Urato, a maternal-fetal medicine specialist in Framingham, MA, tells Endpoints News.
Plans for this hearing have dragged on after FDA first proposed to withdraw Makena’s approval following another 2019 adcomm that voted against keeping the accelerated approval (9-7) after a review of trial results that did not confirm the benefit of Makena as a treatment to reduce the risk of preterm birth.
Covis, meanwhile, insists the data are mixed.
“We are committed to further study to clarify the risk-benefit of this drug, given the inconsistent efficacy outcomes between the landmark Meis study and PROLONG, and the important role Makena plays in this high-risk and underserved patient population,” said Covis CEO Michael Porter in a statement.