Unproven birth drug coming off US 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 drug, 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.

The announcement this week from Covis Pharma comes roughly four years after 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 of the challenges the FDA faces to withdraw a medication when the manufacturer won’t do so voluntarily.

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 several months.

The company said that the extended offramp would give women 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 process to force the drug’s removal on its own terms, according to the company.

In a separate filing Wednesday, the agency’s drug regulators recommended making the withdrawal “immediately effective.”

The agency noted there’s no indication of “harm from discontinuing Makena, such as signs or symptoms of withdrawal.”

The FDA granted Makena accelerated approval in 2011 based on a small study in women with a history of early deliveries.

In 2019, results from that 1,700-patient study showed the drug neither reduced premature births, as originally thought, nor resulted in healthier outcomes for infants.