FDA Approves Ozempic to Reduce Kidney Disease Progression in Patients with Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) announced on January 28th, 2025, that Ozempic (semaglutide, Novo Nordisk) is now approved to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD). The approval came from phase 3 results of the FLOW trial. 

This approval is a significant advancement for people managing both conditions. 

What is the Connection Between Chronic Kidney Disease and Diabetes?

Chronic kidney disease (CKD) is a serious and common condition affecting approximately 37 million adults in the United States. A major cause of CKD is type 2 diabetes, with nearly 40% of people with diabetes also developing kidney disease. CKD can worsen over time, leading to kidney failure, which requires dialysis or a kidney transplant. Additionally, people with CKD and diabetes face a higher risk of cardiovascular problems, including heart attacks and strokes.

How Ozempic Helps Patients with CKD and Diabetes

Ozempic was already approved to help lower blood sugar levels and reduce the risk of major cardiovascular events such as heart attacks and strokes in adults with type 2 diabetes. With this new FDA approval, Ozempic is now also recognized for its ability to slow kidney disease progression and reduce the likelihood of kidney failure and cardiovascular-related deaths in patients with type 2 diabetes and CKD.

Evidence Behind the Approval: FLOW Trial Results

The FDA based its approval on findings from the FLOW phase 3b kidney outcomes trial. This trial included 3,533 adults with type 2 diabetes and CKD and compared the effects of once-weekly Ozempic injections against a placebo. Results showed a 24% reduction in the risk of kidney disease worsening, kidney failure, and cardiovascular death in those receiving Ozempic. Because of these promising results, the study was stopped early after reaching its pre-specified efficacy criteria.

"Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease, and I have seen in my own practice that patients with type 2 diabetes and chronic kidney disease need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes. A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today's decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients." - Richard E. Pratley, MD, Medical Director at the AdventHealth Diabetes Institute Orlando, FL, and Co-Chair of the FLOW Trial.

What This Means for Patients

For individuals with both type 2 diabetes and CKD, Ozempic offers an important new treatment option to help protect kidney function and reduce cardiovascular risks. Managing both conditions effectively can slow disease progression and improve overall health outcomes.

If you have type 2 diabetes and CKD, speak with your healthcare provider to determine if Ozempic could be a suitable addition to your treatment plan. To learn about additional strategies you can implement to support your kidney health, click here. 

Conclusion

The FDA's approval of Ozempic for reducing the risk of kidney disease worsening and cardiovascular death marks an important milestone for patients with type 2 diabetes and CKD. With clinical trial evidence supporting its effectiveness, Ozempic offers additional hope in aiding patients against these serious health conditions. If you or a loved one is managing both type 2 diabetes and CKD, consult your doctor to learn more about this newly expanded treatment option. 

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Sources: 

• Press Release: FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
• CKD Prevalence Among Patients With and Without Type 2 Diabetes: Regional Differences in the United States
• Diabetes and Chronic Kidney Disease
• Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes