The U.S. Food and Drug Administration has withdrawn its approval of an unproven drug intended to prevent premature birth.
Manuel Barce Seneta/AP
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Manuel Barce Seneta/AP
The U.S. Food and Drug Administration has withdrawn its approval of an unproven drug intended to prevent premature birth.
Manuel Barce Seneta/AP
The Food and Drug Administration is withdrawing approval of a controversial drug aimed at preventing premature birth, but its studies have shown it is ineffective.
The FDA’s decision came abruptly on Thursday after years of back and forth between the FDA and pharmaceutical company Covis Pharma. According to the agency’s statement, that means the drug, Makena, and its generics are no longer approved drugs and can no longer be “legally distributed in interstate commerce.”
“It is tragic that scientific research and the medical community have yet to discover treatments that have been shown to be effective in preventing premature births and improving neonatal outcomes,” said FDA Commissioner Robert. M. Caliph said in a statement on Thursday.
Hundreds of thousands of babies are born prematurely in the United States each year. report It was released last year on March of Dimes. Also, preterm birth rates are highest among black infants compared to other racial and ethnic groups.
Last month, Covis said it would voluntarily exit Makena, but hoped to scale the process down over the next few months. On Thursday, the FDA rejected the proposal.
Makena received so-called accelerated approval in 2011. Accelerated approval allows the drug to reach the market sooner because the approval is based on early data. But there are pitfalls. Pharmaceutical companies should conduct follow-up studies to confirm that these drugs actually work.
A later study of Makena was disappointing, and in 2020 the FDA recommended discontinuing use of the drug. However, Covis did not voluntarily remove the drug at the time, so two years later he had a hearing in October to discuss the possibility.
Ultimately, a panel of outside experts voted 14 to 1 to remove the drug from the market.
However, the FDA Commissioner still had to make a final decision.
In their decision to stop the drug immediately, Califf and chief scientist Namandjé Bumpus consulted one of the agency’s advisors, Dr. Anjali Kaimalprofessor of obstetrics and gynecology at the University of South Florida.
Kaimal said another trial is needed to test the drug’s effectiveness, but in the meantime, it makes no sense to administer drugs to patients that appear to have no effect. ”
