The maker of the drug Makena, which was approved more than a decade ago to reduce the risk of preterm birth, said Tuesday that it is moving to withdraw the medication from the market after a US Food and Administration panel said it is not effective.
“While we stand by Makena’s favorable risk-benefit profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Chief Innovation Officer Dr. Raghav Chari said in a news release.
In October, the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large study failed to show that it was effective. It also voted that a postmarket trial didn’t show any benefit to babies and that the evidence didn’t show that Makena reduced the risk of preterm birth in women who had had one before.
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Covis says that soon after the committee hearing, it outlined a plan for withdrawal that included a wind-down period allowing patients to finish the 21-week course of treatment. However, the FDA’s Center for Drug Evaluation and Research rejected the plan.
“Covis remains prepared to work cooperatively with the Agency to accomplish an orderly wind-down and withdrawal of Makena and its generics from the market,” the company said Monday in a letter to FDA Commissioner Dr. Robert Califf and Chief Scientist Dr. Namandje Bumpus. “If a final order withdrawing the approval of Makena is issued, we respectfully request that the effective date of the order be set to allow for an orderly wind-down that would best serve the interests of the patients.”