FDA Pulls Makena Approval Immediately
Rejecting a Covis Pharma proposal for a voluntary phased withdrawal of its preterm birth drug Makena (hydroxyprogesterone caproate injection) over several months, FDA commissioner Robert Califf and chief scientist Namandjé Bumpus said 4/6 that “Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.” The drug had received accelerated approval to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth, an FDA statement says.
When a required confirmatory study did not verify clinical benefit, CDER proposed withdrawing the drug’s approval in 2020. Covis requested a hearing that was held by the Obstetrics Reproductive and Urologic Drugs Advisory Committee on 10/19/2022. Following the hearing, at which the panel voted 14-1 to recommend the withdrawal, presiding officer Celia Witten, CDER deputy director, recommended to Califf and Bumpus that Makena be withdrawn from the market because it does not have a favorable risk/benefit profile.
Covis says it had sent to the agency 10/31/22 its plan for voluntary withdrawal that was not agreed to by CDER. In a 3/6 letter to Califf and Bumpus, the company had said it was still willing to “work cooperatively with the agency to effectuate an orderly wind-down.”
The company had asked that the effective date of any withdrawal order be set to allow for an orderly wind-down that would best serve the interests of patients. It asked that any order give at 21 weeks from the date of the order so patients could complete their courses of treatment and for the remaining in-channel inventory to be exhausted.
In its statement, FDA says the “agency recognizes that there is a supply of product that has already been distributed. Patients who have questions should talk to their healthcare provider. Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved.”
Califf said it is tragic that scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes, particularly because this serious condition has a disparate impact on communities of color, especially black women. But, he said, “the touchstone of FDA drug approval is a favorable benefit/risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”