Covis Willing to Voluntarily Withdraw Makena
Covis Pharma says it remains willing to voluntarily withdraw its pre-term birth drug Makena (hydroxyprogesterone caproate injection) and to work with CDER on an orderly wind-down. In a 3/6 letter to FDA commissioner Robert Califf and chief scientist Namandjé Bumpus, responding to the 1/19 report of a hearing presiding officer, the company says it had offered a plan for withdrawing the drug that was rejected by CDER.
“Shortly following the hearing, on 10/31/22, Covis outlined a plan of orderly voluntary withdrawal that would have obviated the need for further proceedings by the presiding officer or before the Office of the Commissioner,” the company writes. “CDER was not, however, in agreement with the plan outlined by Covis. Covis remains willing to voluntarily withdraw the product and to work cooperatively with the agency to effectuate an orderly wind-down.”
Following a 10/19/22 withdrawal hearing by the Obstetrics Reproductive and Urologic Drugs Advisory Committee, CDER deputy director Celia Witten, the hearing’s presiding officer wrote to Califf and Bumpus recommending that Makena be withdrawn from the market because it does not have a favorable risk/benefit profile. The panel had voted 14-1 to recommend the withdrawal.
According to Witten, based on the “analyses presented at the hearing, I do not believe effectiveness has been demonstrated in any subgroup and think that for this reason the benefit/risk considerations do not favor keeping Makena on the market to preserve access. I also share the view that maintaining an ineffective treatment on the market may impede development of other products for Makena’s labeled indication….” Witten wrote that there are known risks and a potential for other risks, including intergenerational safety risks.
The Covis letter says that if a final order withdrawing Makena’s approval is issued, the company requests that the effective date be set to allow for an orderly wind-down that would best serve the interests of the patients. It asks that any order give at least 21 weeks from the date of the order so patients may complete their courses of treatment and for the remaining in-channel inventory to be exhausted.
While reiterating its willingness to withdraw Makena, Covis also raises a concern that the way Witten changed the wording of a decision question on whether Makena should remain on the market while an appropriate confirmatory study is designed and conducted during the hearing “may well have skewed the resulting vote and not fully reflected the robust discussion at the hearing. In particular, we believe that the revisions to Question 3 limited the ability of the committee members to vote on whether Makena should remain on the market with a narrowed indication for higher-risk women.”