The drug Makena, meant to reduce the risk of preterm birth, is being pulled from the market by its maker.
Covis, the company that makes the drug, announced Tuesday that it is moving to withdraw the medication from the market after a US Food and Administration panel said it is not effective, CNN reported.
“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.
The decision by Covis was made after the FDA advisory committee agreed unanimously in October that a large study showed that the drug offered no benefit to newborns, The New York Times reported.
According to Covis, the company outlined a plan for withdrawal that included allowing patients to finish the 21-week course of treatment. The FDA’s Center for Drug Evaluation and Research rejected that plan, CNN reported.
“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.
“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.”
The drug had been approved for use more than a decade ago.