MAKER OF UNPROVEN BIRTH DRUG MAKENA TO PULL IT FROM MARKET
FDA regulators urge drug’s immediate withdrawal from U.S.
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 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 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 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.”
FDA Commissioner Robert Califf is expected to soon decide on the drug’s fate, in consultation with the agency’s top scientist. use over several