Maker of unproven birth drug Makena to pull from U.S. market

WASHINGTON — The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to force it from the market.

The announcement late Tuesday from Covis Pharma comes roughly four years after the company’s drug, Makena, failed to show a benefit in helping mothers carry pregnancies to term.

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 for the challenges the FDA faces to withdraw a medication when the manufacturer won’t do so voluntarily.

Indeed, the timing of the drug’s removal remains uncertain. Covis, based in Switzerland, said in its release that FDA regulators rejected its proposal to wind down the drug’s use over more than six months.

The company said that extended off-ramp would give women who are still receiving the drug time to finish their course of treatment, which involves weekly injections starting after 16 weeks of pregnancy.

But the FDA made clear it would continue its internal process to force the drug’s removal on its own terms, according to the company. FDA Commissioner Robert Califf is expected to soon decide the drug’s fate, in consultation with the agency’s top scientist.

Covis said it made its proposal to the FDA following an October public meeting at which outside advisers overwhelmingly concluded that Makena hasn’t been shown to work and should have its approval revoked. Despite hours of presentations and debate, the panel was unconvinced by arguments from Covis that the drug could be useful for a subgroup of women.

Such hearings are extraordinarily rare and occur only after a drugmaker rejects initial FDA requests to pull its drug.

“While we stand by Makena’s favorable benefit-risk 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,” said Raghav Chari, Covis’ chief information officer, in a statement.

The company added that it “remains ready to work cooperatively with the agency,” to remove the drug, despite disagreement on the timeframe.

About 10% of U.S. births come too early, before 37 weeks, raising the risk of serious health problems and even death in infants. About 350,000 women have used Makena in the last decade, Covis says.