Only the drug to prevent premature births will be removed from the United States

Jhe maker of the only drug approved to reduce the risk of preterm birth in the United States wants to pull it from the market – gradually – years after research raised questions about its effectiveness.

Apollo Global Management’s Covis Pharma group said it was trying to remove Makena in an orderly fashion after a US Food and Drug Administration advisory committee recommended withdrawing its approval at a meeting in October. While the drug gained fast-track approval in 2011, a later study to confirm its benefits found it performed no better than older drugs.

A division of the FDA draw proposal the drug on the market in 2020 based on its conclusion that the study did not show Makena to be effective for its intended use.

The situation adds to controversy around fast-track approvals in the United States, which allow experimental drugs to be given to patients based on preliminary data suggesting they will have a significant benefit. The follow-up research needed to validate these expectations is often delayed, studies show, meaning patients risk being exposed to questionable treatments for years.

Learn more: You can do everything “right” and still have a premature birth

Withdrawing Makena immediately would be disruptive to patients who are currently in the middle of the 21-week treatment, the company said in a statement. statement, noting that it has no significant security issues. He asked the agency to set an “effective date” to end sales of the drug and its generic equivalents, which would allow its use to end.

“We are looking to voluntarily withdraw the product,” said Raghav Chari, Chief Innovation Officer of Covis. “We acknowledge the attention the agency has given to this issue, especially given the complexity of 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 sees as a favorable risk-benefit profile for Makena, which is aimed at women who have already given birth prematurely.

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