GLP-1 drugs are being studied in a growing number of indications, and Novo Nordisk can now claim to have the first medication in this class approved for chronic kidney disease.
The FDA has expanded the label of Ozempic, approving the Novo Nordisk product for reducing the risk of worsening kidney disease and kidney failure as well as reducing the risk of death. The new approval announced Tuesday covers use of the drug in patients who have both type 2 diabetes and chronic kidney disease. Type 2 diabetes is a risk factor for developing chronic kidney disease.
The main pharmaceutical ingredient in Ozempic is semaglutide, a peptide engineered to mimic the GLP-1 hormone in our bodies. This drug binds to and activates the GLP-1 receptor to trigger metabolic effects. Ozempic was initially approved in 2017 for the management of blood glucose in patients with type 2 diabetes. Three years later, the FDA expanded the product’s approval to include reducing the risk of major cardiovascular events — heart attack, stroke, or death — in adults with type 2 diabetes and known heart disease.
The latest Ozempic approval is based on the results of a placebo-controlled Phase 3 clinical trial that evaluated the drug in adults with type 2 diabetes and chronic kidney disease. The main goal was a composite endpoint comprised of five measures of kidney health. An interim look at the data showed the drug was so successful on these measures that Novo Nordisk was able to stop the study early. When the results finally came out, they revealed the once-weekly injection reduced the risk of kidney disease complications by 24% compared to a placebo, which was statistically significant.
An estimated 37 million adults in the U.S. have chronic kidney disease, according to Novo Nordisk. That number is expected to rise with an aging population and the increasing prevalence of diabetes.
“This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated,” Anna Windle, senior vice president clinical development, medical & regulatory affairs at Novo Nordisk, said in a prepared statement. “With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 [receptor agonist] in its class.”
Wegovy, the blockbuster Novo Nordisk obesity drug, also contains semaglutide as the main ingredient, but at different doses than Ozempic. Last March, the FDA expanded Wegovy’s approval to include reducing cardiovascular risks in adults with cardiovascular disease and either obesity or overweight. The company is also seeking to expand Wegovy’s label to include the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH). Eli Lilly, the Danish company’s main metabolic medicines rival, is also seeking to expand the approved uses of its GLP-1 and GIP receptor agonist obesity drug, Zepbound. In late 2024, the FDA approved Zepbound as a treatment for obstructive sleep apnea.
Ozempic is Novo Nordisk’s top-selling product, accounting for 86.4 billion Danish krone (about $12 billion) in revenue in the first nine months of 2024. The vast majority of those sales were in North America, according to the company’s financial reports.
The latest FDA approval expands the market for Ozempic even as the product faces coming pricing challenges. Ozempic, Rybelsus, and Wegovy — all of which contain semaglutide as the main ingredient — are among the 15 drugs selected for price negotiation with the Centers for Medicare & Medicaid Services. Novo Nordisk objects to the grouping of multiple products it contends would not meet the law’s requirements if considered individually. But federal officials said that selection of a drug for price negotiation under the law covers all dosage forms and strengths of a pharmaceutical ingredient, even if that ingredient is marketed under different brand names. Negotiated prices for this group of drugs would take effect in 2027.
Photo by Novo Nordisk
