Maker of unproven birth drug Makena to pull from US market
FDA: Treatment failed to show benefit of carrying pregnancies to term
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 removal announcement Tuesday from Covis Pharma comes roughly four years after Makena failed to show a benefit in helping people 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 several months.
The company said that extended offramp would give people 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. 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.”
FDA Commissioner Robert Califf is expected to soon decide on the drug’s fate, in consultation with the agency’s top scientist.
Covis 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 patients.
Such hearings are extraordinarily rare and occur only after a drugmaker rejects initial FDA requests to pull its drug.