The maker of an unproven drug to prevent premature births has said it will voluntarily withdraw the product from the United States, after regulators announced plans to follow through on a long-delayed effort to force it out of the market. market.
The drug, Makena, is a synthetic version of the hormone progesterone, which is needed to maintain pregnancy. It is the only drug approved by the FDA to reduce the risk of premature birth.
Covis Pharma’s withdrawal announcement on Tuesday comes about four years after Makena failed to show benefit in helping mothers carry their pregnancies to term.
Since then, the Food and Drug Administration has taken steps to remove the drug from the market, although Covis has repeatedly asked for more time to conduct additional research. The injectable drug has become a symbol of the challenges the FDA faces in removing a drug when the manufacturer does not voluntarily do so.
Indeed, the timing of drug withdrawal remains uncertain. Switzerland-based Covis said in its statement that FDA regulators rejected its proposal to curtail use of the drug over several months.
The company said an extended ramp-out would give women who are still receiving the drug time to complete their treatment, which involves weekly injections beginning after 16 weeks of pregnancy. For now, Covis continues to market Makena.
“There may be some confusion about the current status of Makena. Makena remains available to patients and prescribers,” the company says on its website.
But the FDA has made it clear that it will continue its internal process to force the withdrawal of the drug on its own terms, according to the company. FDA Commissioner Robert Califf is expected to decide the drug’s fate soon, in consultation with the agency’s top scientist.
Covis defends benefits of Makena for some women
Covis made its proposal to the FDA following an October public meeting in which outside advisers overwhelmingly concluded that Makena had not been shown to work and that approval should be sought. revoked. Despite hours of presentations and debates, the panel was unconvinced by Covis’ arguments that the drug might be helpful to a subset of women.
Such hearings are extremely rare and only take place after a drugmaker has rejected the FDA’s initial requests to withdraw its drug.
“While we stand by Makena’s favorable benefit-risk profile, including its effectiveness in women most at risk of preterm birth, we seek to voluntarily withdraw the product and work with the FDA to effect an orderly reduction. “said Raghav Chari, Chief Information Officer of Covis, in a statement.
The company added that it “remains ready to work cooperatively with the agency” to withdraw the drug, despite a disagreement over the timeline.
About 10% of births in the United States occur too early, before 37 weeks, which increases the risk of serious health problems and even death in infants. The problem occurs at higher rates in black women.
The FDA granted accelerated approval to Makena in 2011 based on a small study in women with a history of early childbirth. The fast-track approval was conditional on a larger follow-up study to confirm whether the drug leads to better health outcomes for babies.
In 2019, the results of this international study involving 1,700 patients showed that the drug did not reduce preterm births – as originally thought – or lead to healthier outcomes for infants.
Despite these findings, reproductive experts — including the American College of Obstetricians and Gynecologists — have argued for the decade-old drug to be available while more research is done.
A spokesperson for the group said Wednesday it will await the FDA’s final decision on the drug.