The maker of the only drug approved to reduce the risk of premature labor in the U.S. wants to pull it off the market—gradually—years after research raised questions about how well it works.
Apollo Global Management’s Covis Pharma Group said it is trying to withdraw Makena in an orderly fashion after a U.S. Food and Drug Administration advisory panel recommended retracting its approval at a meeting in October. While the medicine had won accelerated approval in 2011, a subsequent study intended to confirm its benefits found it didn’t work better than older drugs.
An FDA division proposed pulling the drug from the market in 2020 based on its conclusion that the study didn’t show Makena was effective for its intended use.
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The situation is adding to the controversy around expedited approvals in the U.S., which allow experimental drugs to be given to patients based on preliminary data that suggests they will have a significant benefit. The follow up research required to validate those expectations is often delayed, studies show, meaning patients are at risk of being exposed to questionable treatments for years.
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Makena’s immediate withdrawal would be disruptive to patients who are currently in the middle of the 21 week course of treatment, the company said in a statement, noting that it doesn’t have any significant safety concerns. It requested that the agency set an “effective date” to end sales of the drug and its generic equivalents that would allow its use to wind down.
“We are seeking to voluntarily withdraw the product,” said Raghav Chari, Covis’ chief innovation officer. “We recognize the attention the agency has directed to this issue, particularly given the complexity around withdrawing a drug with mixed efficacy data and a positive safety profile.”
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The company also said it stands by what it considers a favorable risk-benefit profile for Makena, which is for women who have previously given birth prematurely.