Ozempic reduces the risk of dying from kidney disease

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Was standing: 03.06.2024, 04:52

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Ozempic is prescribed to diabetes patients and is also considered a weight loss agent. Now a new study shows that it also helps with kidney disease.

The active ingredient in the best-selling drug Ozempic significantly reduces the risk of complications in chronic kidney disease, according to the results of a multi-year study published on Friday (May 24). The study, which was financed by Ozempic manufacturer Novo Nordisk and involved 3,533 patients from all over the world, was presented at the European Renal Association meeting in Stockholm and New England Journal of Medicine published.

It found that patients who received semaglutide – the main active ingredient – had a 24 percent lower risk of dying from cardiovascular and kidney disease than patients who received a placebo. The results were so striking that in October the company announced it was stopping the study early, causing shares in some dialysis companies to fall.

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

Ozempic manufacturer Novo Nordisk wants to approve drug for kidney disease

Novo Nordisk plans to seek approval from the Food and Drug Administration (FDA) later this year to update Ozempic’s labeling for use in patients with chronic kidney disease, which affects an estimated 850 million people worldwide. In the United States, the disease affects more than one in seven adults. The company declined to say when it plans to submit its application to the FDA.

“This study underscores our commitment to making a meaningful difference in the lives of people living with type 2 diabetes and kidney disease,” said Michael Radin, medical director at Novo Nordisk, in a statement. Ozempic belongs to a class of drugs called GLP-1 agonists, which mimic a gut hormone that regulates hunger and blood sugar. Ozempic came to market in 2017 to treat type 2 diabetes, one of the most common causes of kidney disease. The company repackaged the drug semaglutide in 2021 under the name Wegovy to treat people with obesity or overweight and another chronic condition.

The drug’s cardiovascular benefits have recently been demonstrated, and research is underway into its potential effects on other conditions, such as addiction, sleep apnea and Parkinson’s disease. In March, the FDA approved Wegovy as a way to reduce cardiovascular risk in overweight adults, the first approval of its kind.

Is Ozempic approved in the US for chronic kidney disease?

FDA spokeswoman Amanda M. Hils said the agency does not speculate on future regulatory actions, such as expanding Ozempic’s labeling. “The FDA continues to monitor the safety of all approved products, including GLP-1 drugs for all approved uses, and works with companies submitting applications to the FDA to ensure 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 in high demand among consumers, leading to frequent shortages, and they have reshaped the culture and discussion around weight, dieting and food consumption. Early on, some doctors raised concerns about the drugs’ effects on kidney function, said Melanie Jay, an associate professor of medicine at NYU Grossman School of Medicine and director of the Comprehensive Obesity Program. The study, which includes more than three years of data, proves otherwise, Jay said.

“Given that kidney disease is so deadly, the risk-benefit analysis is clear,” Jay said. However, she pointed out that the study participants were predominantly white; only 4.4 percent were black. In the United States, African Americans are at higher risk for kidney disease and suffer more severe disease, so Jay said studies need to determine whether the drug has the same effects in those patients. “This is a big problem and people need to be aware of it,” Jay said.

Medicare may not cover the cost of weight loss medication

Federal law prohibits Medicare – the government health insurance program for older Americans – from covering weight-loss drugs. But plans that participate in Medicare’s voluntary drug prescription program 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, this is a backdoor way to offer weight-loss drugs to Medicare beneficiaries,” said Tricia Neuman, senior vice president at KFF.

Wall Street’s reaction to the release of the trial results on Friday was muted because preliminary results had been released earlier. In a research note, Citigroup analyst Peter Verdult called concerns about whether the promising results would hold in other racial and ethnic groups, and in patients with different baseline weights or levels of kidney damage, a “red herring.” “The subgroup analysis was almost entirely in favor of semaglutide,” he wrote.

Analysts expect the market for semaglutide, which is already seeing record sales, to grow significantly. According to Citigroup, “only” 20 percent of type 2 diabetes patients in the United States and 6 percent worldwide take the GLP-1 drugs.

Daniel Gilbert contributed to this report.

We are currently testing machine translations. This article has been automatically translated from English into German.

This article first appeared in English on May 25, 2024 on the “Washingtonpost.com” – as part of a cooperation, it is now also available in translation to readers of the IPPEN.MEDIA portals.