WASHINGTON. On Thursday, the Food and Drug Administration ordered an immediate withdrawal from the market of a drug meant to prevent preterm labor that has remained available for years despite data showing it does not help pregnant women.
The decision follows repeated attempts by Swiss drugmaker Covis Pharma to keep Makena in the US market while it conducts more research. This drug was the only drug approved in the US to reduce the risk of preterm birth in women with a history of preterm birth.
In recent months, Covis has finally succumbed to pressure from the FDA, offering a “roll-off” period of several months to allow women on the drug to complete their treatment. The FDA rejected that and said on Thursday that action against Makena and several generics should take effect immediately.
“Makena and its generics are no longer approved and cannot be legally distributed in interstate commerce,” the agency said in a statement.
The decision by FDA Commissioner Robert Kaliff and the agency’s chief scientist marks the first time the FDA has formally forced the withdrawal of a drug that was originally approved based on promising early evidence. In all previous cases, drug manufacturers voluntarily withdrew drugs after the FDA made it clear that it intended to withdraw them.
The injectable is a synthetic version of the hormone progesterone, which helps the uterus maintain a pregnancy.
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The FDA expedited approval of Makena in 2011 based on a small study that suggested it reduced preterm birth rates in women who had previously had trouble carrying a pregnancy to term. But results from a 1,700-person study completed in late 2018 showed that the drug does not reduce preterm birth as originally thought, nor does it lead to healthier outcomes for babies.
Since then, the FDA has been working to take the drug off the market, although Covis has repeatedly asked for more time to conduct further research.
In October, the company failed to convince a panel of external FDA consultants that the drug should remain on the market for certain women.
“It is tragic that scientific research and the medical community have yet to find a treatment that has proven effective in preventing preterm birth and improving neonatal outcomes,” Kaliff said in a statement Thursday.
The Food and Drug Administration (FDA) has faced the need to crack down on unproven drugs approved under its accelerated approval program, which has launched dozens of drugs since the early 1990s based on first results.
The downside of the program is that medications will be abandoned if their original promise is not supported by more recent research. Researchers and government watchdogs have documented problems with FDA oversight, including delays in rapidly removing drugs due to failed or missing confirmatory studies. Over the past two years, the Food and Drug Administration (FDA) has stepped up efforts to revoke unproven approvals, mostly for cancer treatments.
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