WASHINGTON – Federal health advisers have concluded that a drug intended to prevent premature births has not proven successful, paving the way for US regulators to pursue long-overdue efforts to take it off the market.
The Food and Drug Administration’s advisory committee voted Wednesday 14-1 to withdraw the injectable drug Makena, despite pleas from the manufacturer to keep it available pending additional research.
Experts essentially approved a 2020 FDA decision that deemed the drug ineffective and called for it to be removed. The manufacturer, Covis Pharma, has challenged that decision, and held a rare public hearing this week.
“If we allow Makena to remain in the market, that means the FDA looked at a large study, found no benefit, and yet allowed this drug to remain on the market,” said obstetrician Dr. Margery Gass. “I think that’s a bad precedent.”
Gass and other committee members encouraged Covis to continue studying the drug to determine if a subgroup of women might benefit.
“I think our patients deserve an answer and they deserve that well-designed clinical trial and I think taking the drug off the market will allow that,” said Dr. Mary Moon of the University of South Alabama.
FDA Commissioner Dr. Robert Califf is expected to make a final decision on whether to withdraw the drug in the next several months. If he follows the committee’s advice, it would be the first time the FDA has formally withdrawn a drug that it initially approved based on promising early data.
Read more: How warming temperatures due to climate change shorten gestation periods
The Food and Drug Administration (FDA) granted McKenna express approval in 2011 based on one small study that appeared to reduce the rate of preterm birth in women with a history of the problem. Premature birth increases the risk of disability and death in infants and affects about 10% of births in the United States.
FDA approval was conditional on a larger follow-up study to confirm whether Makena leads to health outcomes for children.
But in 2019, results from that international study of 1,700 patients showed that the drug did not reduce premature births – as originally thought – nor did it produce healthy outcomes for infants.
The Food and Drug Administration has been moving to revoke approval of the drug ever since. But the lengthy bureaucratic process underscores the difficulty of removing the drug from the market when the manufacturer does not do so voluntarily.
Luxembourg-based Covis Pharma argued this week that McKenna benefits women at high risk of preterm birth, including black Americans, and suggested narrowing its consent to that group while it conducts another study to confirm efficacy. Presentations by the company included outside experts who said removing Makena would exacerbate racial disparities in prenatal care.
“The FDA must do what’s best for our patients, which is to keep this drug available to those who manage these high-risk patients every day,” Dr. Yolanda Lawson, an obstetrician at Baylor University, told the FDA. Team.
But the experts eventually sided with the Food and Drug Administration scientists, who asserted that they were “unable to identify a group of women on whom McKenna had an effect.” The Food and Drug Administration noted that the drug also has risks, including blood clots and depression.
Read more: Home births are becoming more common during the pandemic. But many insurance companies still do not cover it
The US Food and Drug Administration has faced pressure to crack down on unconfirmed drugs approved under it Expedited Approval Program, which has allowed the release of dozens of drugs based on early results since the early 1990s. The flip side of the program means drugs are removed if subsequent studies don’t confirm their initial promise.
McKenna has become something of a poster child for the negative aspects of the program, as the drug has been on the market for more than a decade with no proven benefit. According to a recent federal report, the United States has spent $700 million on Makena since 2018 through various government programs, including Medicaid.
According to Covis, about 350,000 women have used the drug in the past decade.
Even if the drug is removed, it is expected that some clinicians will continue to prescribe its main components as a specialist drug. Compound pharmacies have always offered their own formulations of the drug. Both Makena and the combination medication consist of a synthetic form of the hormone progesterone, which helps the uterus grow and maintain a pregnancy.
More must-read stories from TIME
Discussion about this post