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Covis’ controversial Makena gets FDA hearing date in bid to stay on the market

More than a decade after Makena’s FDA approval to prevent recurrent preterm birth and two years after the FDA recommended the drug be pulled from the market, Covis Pharma has locked down a hearing date to fight for the med’s future.

The agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee will meet from October 17 to 19 to discuss the medicine and hear Covis’ argument that it should stay on the market.

The meeting is a long time coming. Last August, the FDA granted Covis a chance to plead its case against the agency’s recommendation to pull the accelerated approval for Makena and its five generic versions.

The FDA’s withdraw request came after an advisory committee in 2019 voted 9 to 7 that Makena should be pulled. The panel made its decision after reviewing confirmatory trial results, which did not confirm the med’s benefits over placebo.

Makena is the only approved treatment to reduce the risk of recurrent preterm birth in women who have have a history of spontaneous preterm birth. That underserved patient population led the FDA to grant accelerated approval in 2011 based on positive findings from a placebo-controlled trial with 463 participants.

Covis isn’t letting the drug go down without a fight. It will present new proposed study options at the hearing and hopes the agency will let the company do additional research on Makena.

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

The FDA was amicable to the hearing when Covis requested it. In a 2020 letter, then-chief scientist Denise Hinton wrote to the company’s attorneys that its response raised “genuine and substantial issues of fact appropriate for a hearing.”

In October 2020, the FDA’s Center for Drug Evaluation and Research (CDER) based the withdraw proposal on the failed results of the med’s postmarketing study. The confirmatory study was supposed to show evidence that the drug provides clinical benefit to newborns. Not only was the drug ineffective in improving the health of newborns, but it was not found to reduce the risk of preterm birth.

As the FDA and Covis work through the Makena case, Congress is reportedly weighing changes to the FDA’s accelerated approval that would give the agency more powers. The Wall Street Journal recently 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.
Over the last year, the agency’s accelerated approval for Biogen’s Alzheimer’s drug Aduhelm stirred controversy, and Biogen has now all but given up on that medicine.