Maker of unproven birth drug Makena to pull from US market
The maker of an unproven drug intended to prevent premature births says it will voluntarily remove the product from the United States
WASHINGTON (AP) — 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.
