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Covis finally pulls preterm birth drug Makena after 12-year accelerated approval odyssey

The advantage for Covis’ Makena has always been clear: It was the only drug available to prevent premature birth.

But, over time, Makena’s disadvantage also became obvious: It didn’t work.

Wednesday, Covis finally agreed to pull Makena off the market after the drug flunked a confirmatory trial and after the company failed to convince two independent advisory committees of its benefits.

The most recent rebuke came five months ago when the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 14-1 to recommend sidelining Makena.

The recommendation was based on trial results that exposed Makena’s ineffectiveness. But the Luxembourg-based company argued that the study was skewed toward white European women and didn’t reflect the benefits Black women in the U.S. had experienced with the injected treatment. Covis wanted more time to make its case for effectiveness in subgroups.

After the vote, the company proposed a wind-down period that would allow patients to complete their 21-week course of treatment using only available inventory. But the FDA did not concur.

“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at the highest risk of preterm birth, we are seeking to voluntarily withdraw the product,” Raghav Chari, Ph.D., Covis’ chief innovation officer, said in a release.

A successful trial of 463 patients paved the way for Makena to be approved in 2011 under the FDA’s accelerated pathway. The hormone treatment was for pregnant women who had a history of spontaneous preterm birth.

In its 12 years on the market, it was provided to more than 310,000 women, according to the Los Angeles Times. And it came with a hefty price tag—$855 per weekly shot.

The first time Makena came under FDA scrutiny was when it came up short its first confirmatory trial versus placebo, showing not only that it did not prevent preterm birth but also that it did not provide clinical benefits to newborns. That culminated in a 2019 advisory committee vote of 9-7 recommending that it be pulled.

Leading up to the October 2022 advisory committee meeting, Covis still was touting its advantage as a one-of-a-kind treatment.

“This need for further study is underscored by the very fact that there are no approved alternatives available for high-risk patients,” Covis CEO Michael Porter said last June.

Covis, which was founded the year Makena was approved, was not the original developer of the drug. KV Pharmaceuticals won the original approval and later rebranded itself as Lumara Health. AMAG Pharmaceuticals then bought Lumara’s maternal health business in 2014.

For its part, Covis picked up the product in its 2020 acquisition of AMAG for $647 million.

Over the years, annual sales of Makena grew steadily, peaking at $387 million in 2017. Two years later—as scrutiny mounted—sales plummeted to $122 million.

Meanwhile, after a high-profile flop with the accelerated approval of Biogen’s Alzheimer’s disease treatment Aduhelm, Congress is reportedly weighing changes to the FDA’s accelerated approval process that would give the agency more powers. The Wall Street Journal reported that the proposals would give the FDA more authority over confirmatory trials, and it wouldn’t have to take as many steps to pull ineffective drugs that were approved under the program.