It's officially the end of the road for Covis’ Makena, as the FDA yanked the medicine's accelerated approval a month after the company agreed to pull it from the market.
The move was well anticipated. After many years on the market, scrutiny around the preterm birth drug's effectiveness emerged following a flopped confirmatory trial and during two FDA advisory committee meetings.
In March, Covis finally threw in the towel and agreed to pull the product. At the time, the company’s chief innovation officer Raghav Chari, Ph.D., said in a release that Covis stood by Makena’s “favorable risk-benefit profile, including its efficacy in woman at the highest risk of preterm birth.”
The more recent advisory committee meeting on the drug was in October, when the FDA’s independent Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 14-1 that the drug should be pulled. That followed a 2019 advisory committee meeting that ended in a 9-7 vote recommending Makena's withdrawal.
The drug was the only approved treatment to reduce the risk of recurrent preterm birth in women who have a history of spontaneous preterm birth. It scored a speedy approval in 2011 through the FDA’s accelerated approval pathway based on the underserved patient population and positive trial results.
Things took a turn when Makena failed a confirmatory study in 2019. Instead of proving clinical benefit to newborns, the drug didn’t improve the health of newborns or reduce the risk of preterm birth. That study caused the FDA’s Center for Drug Evaluation and Research to propose Makena's withdrawal in 2020.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes,” FDA Commissioner Robert Califf, M.D., said in the FDA’s new release, noting that the condition disparately affects women of color, especially Black women. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.”
Covis snatched up Makena in its 2020 acquisition of AMAG Pharmaceuticals. AMAG bought it in 2014 from KV Pharmaceuticals (now Lumara Health), which developed the drug and scored the original 2011 approval.
The drug's sales peaked at $387 million in 2017.