As Reported by The Washington News, A multiyear study published on Friday reveals that the active compound in the best-selling drug Ozempic significantly lowers the risk of complications from chronic kidney disease. This finding could substantially increase the number of patients eligible for these injections.
Funded by Ozempic manufacturer Novo Nordisk and involving 3,533 patients globally, the study was presented at the European Renal Association meeting in Stockholm and published in the New England Journal of Medicine.
The research found that patients receiving semaglutide, Ozempic’s key ingredient, had a 24 percent lower risk of death from cardiovascular and kidney disease compared to those who received a placebo. The results were so compelling that Novo Nordisk stopped the trial early in October, leading to a drop in shares of some dialysis companies.
“These findings offer great promise in reshaping treatment strategies for individuals at high risk of diabetes-related complications,” said Vlado Perkovic, a kidney researcher at the University of New South Wales Sydney.
Novo Nordisk plans to seek Food and Drug Administration (FDA) approval this year to update Ozempic’s label to include use in patients with chronic kidney disease, which affects an estimated 850 million people worldwide and more than one in seven adults in the United States. The company has not specified when it will file its request with the FDA. from CNN
“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.
Ozempic, part of a class of medications known as GLP-1 agonists, mimics a gut hormone that regulates hunger and blood sugar. Introduced in 2017 for Type 2 diabetes, a leading cause of kidney disease, the active ingredient semaglutide was repackaged in 2021 as Wegovy for weight management in obese or overweight individuals with another chronic condition.
These drugs have recently shown cardiovascular benefits, and research is ongoing into their potential effects on other conditions, including addiction, sleep apnea, and Parkinson’s disease. In March, the FDA approved Wegovy to reduce cardiovascular risk in overweight adults, marking the first approval of its kind.
FDA spokeswoman Amanda M. Hils stated that the agency does not speculate on future regulatory actions regarding Ozempic’s label expansion. “The FDA continues to monitor the safety of all approved products, including GLP-1 drugs, for all approved uses,” Hils wrote in an email.
Consumer demand for these weight-loss drugs has led to repeated shortages and has transformed the conversation around weight, dieting, and food consumption.
Initially, some physicians were concerned about the drugs’ effects on kidney function, noted Melanie Jay, an associate professor of medicine at the NYU Grossman School of Medicine. However, the study, which includes over three years of data, suggests the opposite is true.
“Given that kidney disease is so deadly, the risk-benefit analysis is a no-brainer,” Jay said. However, she noted that study participants were predominantly White, with only 4.4 percent being Black. Since African Americans in the U.S. are at higher risk of severe kidney disease, Jay emphasized the need for studies to confirm the drug’s effects in these patients.
“It’s a big issue, and people need to be aware of that,” Jay said.
Federal law prohibits Medicare from covering weight-loss drugs, but plans under Medicare’s voluntary prescription drug benefit can cover GLP-1s for other medical purposes, such as diabetes and cardiovascular risk, according to 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. told by Reuters
Wall Street’s reaction to the study results was muted, as preliminary findings had been released earlier. Citigroup analyst Peter Verdult noted that concerns about the results holding true across different races and ethnicities were largely unfounded, with subgroup analysis favoring semaglutide.
Analysts predict substantial growth in the market for semaglutides, which are already seeing record sales. According to Citigroup, only 20 percent of Type 2 diabetes patients in the U.S. and 6 percent globally currently use GLP-1 drugs.
