WASHINGTON — The Food and Drug Administration on Thursday ordered the immediate withdrawal from the market of a drug designed to prevent premature births that has been available for years despite data showing it does not help pregnant women.
The decision follows repeated efforts by Swiss drug company Covis Pharma to keep Makena on the US market while it conducts further studies. The drug was the only drug approved in the US to help reduce the risk of preterm birth in women with a history of preterm birth.
In recent months, Covis finally bowed to pressure from the FDA, offering a “cooling off” period of several months so women taking the drug could complete their treatment. The FDA rejected that and said Thursday that the action against Makena and several generic versions should take effect immediately.
“Makena and its generics are no longer approved and may not be legally distributed in interstate commerce,” the agency said in a statement.
The decision by FDA Commissioner Robert Califf and the agency’s chief scientist is the first time the FDA has formally ordered the withdrawal of a drug it originally approved based on early promising data. In all previous cases, drugmakers have voluntarily withdrawn drugs after the FDA has made clear that it intends to remove the drug.
The injection is a synthetic version of the hormone progesterone, which helps the uterus maintain a pregnancy.
read more: Why is it so difficult to check your fertility?
The FDA fast-tracked Makena’s approval in 2011 based on a small study that suggested it reduced the rate of preterm birth in women who had previously had trouble ending their pregnancy. But the results of a study of 1,700 participants completed in late 2018 showed that the drug did not reduce premature births as originally thought, nor did it lead to healthier outcomes for babies.
Since then, the FDA has been working to withdraw the drug from the market, although Kovis has repeatedly requested more time to conduct further research.
In October, the company failed to convince a panel of outside FDA advisers that the drug should remain on the market for some women.
“Tragically, the scientific research and medical communities have yet to find a treatment that is effective in preventing preterm birth and improving neonatal outcomes,” Califf said in a statement Thursday.
The FDA has come under pressure to crack down on unproven drugs that have been cleared under its accelerated approval program, which since the early 1990s has allowed dozens of drugs to launch based on early results.
The flip side of the plan means removing drugs if their initial promise is not confirmed by further studies. Researchers and government watchdogs have noted problems with FDA oversight, including delays in rapid clearance of drugs with failed or missing confirmatory studies. In the past two years, the FDA has stepped up efforts to remove unproven approvals, mostly from cancer therapies.
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