Maker of preterm birth drug Makena to withdraw it from market
The drug Makena, which was approved to reduce the risk of preterm birth, is being withdrawn from the market after a US Food and Administration panel said it is not effective.
Makena, a drug that was approved over a decade ago to lower the risk of preterm births, is being pulled from the market by the manufacturer. A panel of US Food and Administration officials deemed it ineffective.
"While we stand behind Makena's favorable risks-benefit profile, which includes its efficacy for women at high risk of preterm delivery, we are seeking voluntarily to withdraw the product and to work with FDA to effectuate a orderly wind down," Dr. Raghav Chari, Chief Innovation Officer at Covis, stated in a news release.
After a large study that failed to prove its effectiveness, FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted in October that Makena should be removed from the market. The FDA's Obstetrics Reproductive and Urologic Drugs Advisory Committee voted against Makena's post-market trial. It also rejected evidence that Makena increased preterm birth rates in women who had used it before.
Covis claims that it presented a plan to withdraw soon after the hearing. It included a wind down period that allowed patients to complete the 21-week treatment. The FDA's Center for Drug Evaluation and Research rescinded the plan.
"Covis is prepared to cooperate with the Agency to achieve an orderly wind down and withdrawal of Makena, and its generics, from the market," the company stated Monday in a letter addressed to Dr. Robert Califf, FDA Commissioner, and Dr. Namandje Bumpus Chief Scientist. We respectfully request that the effective day of any final order removing Makena's approval be set so that patients can benefit from an orderly winddown.