The company that makes Makena, the only drug intended to prevent preterm labor, announced Tuesday it was voluntarily withdrawing the drug from the market after Food and Drug Administration advisers concluded the treatment did not help pregnant women at all.
Makena’s drugmaker, Covis Pharma Group, said its decision it had been done in deference to an FDA advisory committee that unanimously agreed in October that a large study had shown the drug offered no benefit to newborns.
Makena had been cited by critics as a flawed example of the FDA’s accelerated drug approval program because the agency’s original green light for the sale was based on indications that the drug would be effective. But a succession of manufacturers could not provide convincing evidence after years of study that the drug stopped sometimes dangerous preterm births.
Makena is now owned by Covis Pharma Group, a Swiss-based private equity-backed company.
“While we maintain Makena’s favorable risk-benefit profile, including its efficacy in women at increased risk of preterm birth, we seek to voluntarily withdraw the product and work with the FDA to effect an orderly liquidation,” said Raghav Chari, chief innovation officer. from Covis, he said.
The removal of the drug means that many women who have given birth preterm will not have an evidence-backed therapy to use during another pregnancy. While the drug was criticized for giving women false hope, patients and doctors who favored more studies in higher-risk populations spoke in its defense at recent agency meetings.
Despite the dismal results of the latest studies, Makena was the only resource for a End-shutdown risk that disproportionately affects black women and children who are at higher risks of disability or death from preterm birth. The initial study of the drug that led to its accelerated approval in 2011 showed promising signs, but a much larger trial that concluded in 2019 showed no benefit for mothers or babies.
The road to get the drug off the market has been long. The FDA first proposed removing the drug from the market in October 2020. The drug’s sponsor appealed the decision, setting up a lengthy process that led to a hearing last fall.
By October of last year, 15 FDA advisers voted unanimously that the long-term so-called confirmatory study had shown no benefit for babies. All but one agreed that the drug should be withdrawn from the market.
The Covid decision on Tuesday followed the recommendation made last January by Dr. Celia Witten, an agency official and chairwoman of the October hearing, that the drug be withdrawn from the market. Still, Dr Witten said she agreed with a member of the advisory panel that she had acknowledged that staff members might feel an imperative to “do something” when faced with a patient in need.
“I think when we leave something on the market that hasn’t been shown to be effective, we lose other research that could be done,” Dr. Anjali Kaimal, an obstetrician and administrator at the University of South Florida, said during the October hearing. “And the last thing I would say is, again, in the face of that feeling of helplessness: Is false hope really any hope?”
In its Tuesday news release, Covis said it had outlined a voluntary recall plan that included a sell-off period that allowed patients using the drug to complete their treatments and the company to use its remaining inventory.
But the FDA “didn’t agree with the proposal,” Covis said, and let the process move forward to Dr. Witten’s recommendation.
The FDA’s “expedited approval” program aims to grant rapid approval to a drug that addresses a serious and unmet medical need if it shows promise in delivering a benefit to patients. The program has brought about 300 drugs to market in 30 years. It drew harsh criticism for the approval of the Alzheimer’s drug Aduhelm, an expensive drug that many experts criticized as risky and ineffective.
Congressional efforts to alter the accelerated approval process culminated last year with minor changes, including speeding up follow-up studies to confirm whether a drug benefits patients.
The FDA should seek further authority to improve the program, said Dr. Michael Carome, director of End-shutdown research for Public Citizen, a consumer advocacy group. He said agency advisers should review a drug for expedited approval before initial approval is granted. The FDA should also seek authorization to quickly remove a drug from the market when the follow-up study shows no benefit, Dr. Carome said.
“Makena is a classic example,” he said, “where the clock has run too long.”