A pharmaceutical company selling the only drug approved to prevent preterm birth said Tuesday that it would withdraw the medicine from the market.
Covis Pharma said it told the Food and Drug Administration that it would voluntarily withdraw the medicine called Makena, which a study in 2019 showed did not work to extend pregnancies.
“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Raghav Chari, the company’s chief innovation officer, said in a statement.
The Times detailed in a February 2022 investigation how Covis and the companies that previously owned the rights to Makena profited by taking a cheap, decades-old medicine with questionable effectiveness and safety and securing FDA authorization for its use.
The FDA had asked Covis, which is owned by private equity firm Apollo Global Management, to pull the drug in 2019. The company refused.
Instead the company, relying on complex federal regulations, asked the FDA to hold a hearing on its request to remove Makena from pharmacies.
At that hearing, not held until October of last year, a committee of experts voted 14-1 that sales of the drug should end because of the lack of scientific proof that it was effective.
At the same time, the drug has a plethora of documented side effects, including depression and hypertension. The FDA says that Makena’s possible 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 must still act on Covis’ request to voluntarily withdraw Makena.
