Drug to prevent preterm birth withdrawn years after proven ineffective

A pharmaceutical company that sells the only drug approved to prevent preterm birth said on Tuesday it would pull the drug from the market.

Covis Pharma said it told the Food and Drug Administration it was voluntarily discontinuing the drug Makena, which a 2019 study found did not work to extend pregnancies.

“While we maintain Makena’s favorable benefit-risk profile, including efficacy in women most at risk for preterm birth, we are committed to voluntarily withdrawing the product and working with the FDA to ensure an orderly phase-out.” reach,” Raghav Chari, the company’s chief innovation officer, said in a statement.

The Times described in A February 2022 study how Covis and the companies that previously owned the rights to Makena profited from taking a cheap, decades-old drug of questionable efficacy and safety and gaining FDA approval for its use.

The FDA asked Covis, which is owned by private equity firm Apollo Global Management, to withdraw the drug in 2019. The company refused.

Instead, citing complex federal regulations, the company asked the FDA to hold a hearing on its request to remove Makena from pharmacies.

At that hearing, held last October, a panel of experts voted 14 to 1 to stop selling the drug due to a lack of scientific evidence of its effectiveness.

At the same time, the drug has a plethora of documented side effects, including depression and high blood pressure. The FDA says Makena’s potential long-term effects on women and their children are still unknown.

The agency approved Makena 12 years ago despite limited evidence that it worked and objections from an agency scientist.

The FDA has yet to respond to Covis’ request to voluntarily withdraw Makena.