Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular-related death in adults with type 2 diabetes and chronic kidney disease (CKD). 

This milestone solidifies Ozempic® as the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class, adding to its prior approvals for improving glycemic control and reducing major cardiovascular events in adults with type 2 diabetes and heart disease.

Addressing a Critical Health Crisis

CKD is a major public health concern in the U.S., affecting approximately 37 million adults, with type 2 diabetes being the leading cause. Nearly 40% of people with type 2 diabetes also have CKD, which significantly increases their risk of cardiovascular disease and mortality.

“Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities,” said Dr. Anna Windle, Senior Vice President at Novo Nordisk. She emphasized that this new approval allows the company to better address cardiovascular-kidney-metabolic syndrome, a major health burden affecting millions of people.

The expanded indication is particularly significant given the rising prevalence of diabetes and CKD, driven by an aging population and lifestyle factors. Without adequate treatment, CKD can lead to severe complications, including dialysis dependence and increased cardiovascular risks, making new treatment options like Ozempic® a valuable tool for clinicians.

Breakthrough Clinical Evidence

The FDA’s decision was based on the phase 3b results of the FLOW trial, which demonstrated Ozempic®’s substantial efficacy in reducing kidney and cardiovascular risks. The trial showed that Ozempic® 1 mg led to a statistically significant 24% relative risk reduction in:

• Kidney disease progression, 
• Kidney failure, and 
• Cardiovascular death over three years, compared to a placebo. 

The FLOW study, an international randomized controlled trial involving over 3,500 patients, was stopped early based on the drug’s strong efficacy results. This underscores the treatment’s potential to change the standard of care for patients at high risk of kidney and cardiovascular complications.

Expanding Treatment Options for Patients

Since its initial FDA approval in 2017, Ozempic® has been used to treat type 2 diabetes, initially for glycemic control and later for cardiovascular protection. This latest expansion makes it the only GLP-1 RA approved to address both cardiovascular and kidney disease risks.

As CKD prevalence grows, expanding treatment access to effective therapies like Ozempic® could have a significant impact on patient outcomes and quality of life.

*Novo Nordisk, Inc. (2025, January 28). FDA Approves Ozempic To Treat Chronic Kidney Disease. https://openminds.com/market-intelligence/bulletins/fda-approves-ozempic-to-treat-chronic-kidney-disease/  

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