FDA orders the market withdrawal of the only US premature birth drug

The Food and Drug Administration has ordered the immediate market withdrawal of the only drug intended to prevent premature births in the US.

The drug, which remained available on the market for years despite data showing it was not effective, was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries, according to ABC News.

The decision to withdraw it follows efforts by the pharmaceutical company Covis Pharma to keep Makena on the market while additional studies emerged.

In recent months, however, the drugmaker bowed to FDA pressure, proposing a “winding down” period of several months so that women taking the drug could complete their treatment.

The FDA rejected the proposal and said that the action against Makena and several generic versions should take effect immediately.

The decision by FDA Commissioner, Robert Califf, and the agency’s chief scientist marks the first time the FDA has formally forced the removal of a drug that it initially approved based on promising early data.

In all prior cases, drugmakers voluntarily pulled medications after the FDA made clear it intended to order removal.

The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy.

The FDA expedited Makena’s approval in 2011 based on a study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term.

However, results from a 1,700-participant study conducted in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.

The FDA has been working to get the drug off the market since then, though Covis repeatedly appealed for more time to conduct further research.

In October, the company failed to convince a panel of outside FDA advisers that the drug should stay on the market for certain women.