Ozempic cuts risk of death from kidney disease, major study finds

The active compound in the best-selling drug Ozempic markedly lowers the risk of complications from chronic kidney disease, according to a multiyear study published Friday — a finding that could dramatically expand the pool of patients eligible for the injections.

Funded by Ozempic maker Novo Nordisk and involving 3,533 patients around the world, a study released in Stockholm at the European Renal Association meeting and published in the New England Journal of Medicine found that patients receiving semaglutide — the key ingredient — experienced a 24% reduction in risk of death from cardiovascular and kidney disease compared with those who received a placebo. The finding proved so striking that the company announced in October that it was stopping the trial early, sending shares of some dialysis companies falling then.

“These findings offer great promise in reshaping treatment strategies for individuals at high risk of diabetes-related complications,” Vlado Perkovic, a kidney researcher at the University of New South Wales, Sydney, said in a statement announcing the results.

Novo Nordisk intends to seek Food and Drug Administration approval this year to update the Ozempic label for use in patients with chronic kidney disease, which affects an estimated 850 million people worldwide. In the United States, the condition affects more than 1 in 7 adults. The company declined to specify when it intends to file its request with FDA.

“This study highlights our drive to make a meaningful difference in the lives of people living with type 2 diabetes” and kidney disease, said Michael Radin, an executive medical director with Novo Nordisk, in a statement.

Ozempic is part of a class of medications, known as GLP-1 agonists, that mimic a gut hormone that regulates hunger and blood sugar. Ozempic entered the market in 2017 as a treatment for Type 2 diabetes, a leading cause of kidney disease. The company repackaged the active ingredient semaglutide as Wegovy in 2021 for weight management in people who are obese or overweight and have another chronic medical condition.

The drugs were recently shown to have cardiovascular benefits, and research is being conducted regarding potential effects on other conditions, including addiction, sleep apnea and Parkinson’s disease. In March, FDA approved Wegovy as a treatment to reduce cardiovascular risk in adults who are overweight, which was the first approval of its kind.

FDA spokeswoman Amanda M. Hils said the agency does not speculate on future regulatory action, such as expansion to Ozempic’s label.

“The FDA continues to monitor the safety of all approved products, including GLP-1 drugs for all approved uses, as well as working with firms that submit applications to the FDA for approval, ensuring that requirements are met and labeling accurately indicates the safety, quality, and effectiveness of an FDA-approved drug,” Hils wrote in an email.

The weight-loss drugs are highly sought after by consumers, leading to repeated shortages, and they have reshaped the culture and conversation surrounding weight, dieting and food consumption.

Early on, some physicians expressed concerns about the drugs’ effect on kidney function, said Melanie Jay, an associate professor of medicine at the NYU Grossman School of Medicine and director of the comprehensive program on obesity. The study, which encompasses more than three years of data, provides assurance the opposite is true, Jay said.

“Given that kidney disease is so deadly, the risk-benefit analysis is a no-brainer,” Jay said.

But she noted that study participants were overwhelmingly White; only 4.4% were Black. In the United States, African Americans are at higher risk of kidney disease and experience more severe illness, so Jay said studies need to determine whether the same impact from the drug is evident in those patients.

“It’s a big issue, and people need to be aware of that,” Jay said.

Federal law prohibits Medicare — the government health insurance plan for older Americans — from covering drugs used for weight loss. But plans participating in Medicare’s voluntary prescription drug benefit can cover GLP-1s for other medical purposes, such as diabetes and cardiovascular risk, according to researchers at KFF, a nonpartisan health research organization.

“In many ways, it’s a backdoor way of providing weight-loss drugs to people on Medicare,” said Tricia Neuman, a senior vice president at KFF.

Wall Street reaction to Friday’s release of the study results was muted given that preliminary results had been released earlier.

In a research note, Citigroup analyst Peter Verdult described as a “red herring” concerns about whether the promising results would hold true across races and ethnicities and among patients with varying baseline weights or degree of kidney damage.

“Subgroup analysis was almost entirely in favour of semaglutide,” he wrote.

Analysts believe the market for semaglutides, already hitting record sales, will grow significantly. According to Citigroup, “just” 20% of Type 2 diabetes patients in the United States and 6% globally take the GLP-1 drugs.

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Daniel Gilbert contributed to this report.