The company that makes Makena, the only drug aimed at preventing premature birth, on Tuesday voluntarily released the drug after advisers from the Food and Drug Administration concluded the treatment was completely useless for pregnant women. announced that it would withdraw from the market.
Covis Pharma Group, Makena’s pharmaceutical company, decision An advisory panel to the FDA unanimously agreed in October to a large study that showed the drug had no benefit to newborns.
Makena had been cited by critics as a flawed example of the FDA’s expedited drug approval program because the agency’s initial marketing authorization was based on indications that the drug was effective. But after years of research, a series of manufacturers have been unable to provide convincing evidence that the drug will stop dangerous premature births.
Makena is now owned by the Cobis Pharma Group, a Swiss-based private equity backing firm.
“While endorsing Makena’s favorable benefit and risk profile, including efficacy for women at highest risk of premature birth, we are voluntarily withdrawing the product and working with the FDA in an orderly, phased We are trying to achieve downsizing,” said Raghav Chari, Chief Innovation Officer at Covis.
Removal of the drug means that many women who give birth preterm do not have access to evidence-backed treatments they can use during their next pregnancy. Patients and physicians who support further research in the highest-risk population have voiced their support at a recent institutional meeting.
Despite the dismal results of recent research, Makena was the only recourse to health risks that disproportionately affect black women and children who are at higher risk of disability and premature death. Initial studies of the drug showed encouraging signs, but much larger trials that ended in 2019 showed no benefit to mothers or babies.
It was a long road to getting this drug off the market. 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 hearings last fall.
By October of last year, 15 FDA advisers unanimously voted that long so-called confirmatory studies had shown no benefit to babies. All but one agreed that the drug should be withdrawn from the market.
Covis decision on Tuesday followed the recommendations Dr. Celia Witten, the chairman of the October hearing and an official with the agency, called for the drug to be removed from the market this past January. He said he agreed with the advisory board members who acknowledged that officials could feel it was imperative to “do something” when they did.
“I think if you leave something unproven on the market, you’re missing out on other research that could be pursued,” says Dr. Anjali Kaimal, an obstetrician and administrator at the University of South Florida. I was. At a hearing in October. “And the last thing I want to say is that I’ve faced that feeling of helplessness again. Is false hope really hope?”
In a news release on Tuesday, Covis outlined plans for a voluntary withdrawal, including a phased period for patients using the drug to complete their courses and for the company to use remaining inventory.
But the FDA “didn’t agree with the proposal,” Covis said, moving the process forward to Dr. Witten’s recommendations.
The FDA’s “accelerated approval” program aims to grant expedited approval to drugs that address serious unmet medical needs when there is a prospect of patient benefit. The program has brought about 300 medicines to market over 30 years. The approval of the Alzheimer’s drug Aduhelm, an expensive drug many experts criticize as dangerous and ineffective, has come under heavy criticism.
Congressional efforts to change the early approval process culminated last year with minor changes that included speeding up follow-up studies to see if the drug would benefit patients.
Dr. Michael Carrom, director of health research at consumer advocacy group Public Citizen, said the FDA needs to ask for more authority to improve the program. He said the agency’s advisers should consider drugs seeking expedited approval before the first OK is given. The FDA should also seek authority to expedite the removal of the drug from the market if follow-up studies show no benefit, he said, Dr. Carome.
“Makena is a prime example,” he said.
