Covis Pharma To Withdraw Only FDA-Approved Treatment To Prevent Preterm Births

Privately held-Covis Pharma, the maker of Makena (hydroxyprogesterone caproate injection) to reduce the risk of preterm birth, said it is moving to withdraw the medication from the market after an FDA panel said it is not effective.
The treatment was approved twelve years ago in February 2011.
“While we stand by Makena’s favorable risk-benefit 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,” Covis Chief Innovation Officer Dr. Raghav Chari said.
In October, the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large study failed to show that it was effective.
The FDA has sought to pull the approval of hydroxyprogesterone caproate injection since 2020 because the required postmarket study failed to verify clinical benefit.
The agency also concluded that the available evidence does not show Makena is effective for its approved use.
An initial study of the drug, published in 2003 in the New England Journal of Medicine, found that women who took the synthetic hormone in Makena had a 30.7% reduction in having another preterm birth.