The maker of an unproven drug Makena intended to prevent premature births says it will voluntarily remove the product from the U.S.
It comes as regulators signaled plans to follow through on a long-delayed effort to force it from the market.
The drug Makena was approved more than a decade ago to reduce the risk of preterm birth. Its maker, Covis, said that it is moving to withdraw the medication from the market after a U.S. Food and Administration panel said it is not effective.
Makena is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. It’s the only drug with FDA approval to reduce the risk of premature birth.
“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.
Since then the Food and Drug Administration has been moving to get the drug off the market, though Covis has repeatedly appealed for more time to conduct additional research.
The injectable drug has become a symbol of the challenges the FDA faces to withdraw a medication when the manufacturer won’t do so voluntarily.
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.
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