FDA Expands Ozempic Approval to Protect Kidney (and Heart) Health in People with Type 2 Diabetes and Chronic Kidney Disease 

Last month, the U.S. Food and Drug Administration (FDA) 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 decision was based on results from the FLOW phase 3 clinical trial.

This expanded approval represents a major advancement for people managing both conditions, offering an additional tool to protect kidney function and heart health.

The Link Between Chronic Kidney Disease and Diabetes

Chronic kidney disease (CKD) is a serious and prevalent condition affecting about 30% of people living with diabetes. CKD can progress over time, potentially leading to kidney failure that requires dialysis or a transplant. Additionally, individuals with both CKD and diabetes face an elevated risk of cardiovascular complications, including heart attacks and strokes.

How Ozempic Benefits Individuals with Diabetes and CKD

Semaglutide (Ozempic) is a commonly used GLP-1, that not only lowers blood glucose levels and body weight, it has also been proven to reduce the risk of major cardiovascular events in adults with type 2 diabetes.

Now, with this latest FDA approval, semaglutide is also recognized for its ability to slow kidney disease progression and lower the risk of kidney failure and cardiovascular-related deaths in people with type 2 diabetes and CKD.

The Science Behind the Approval: FLOW Trial Results

The FDA’s decision was based on the FLOW phase 3b kidney outcomes trial, which involved 3,533 adults with type 2 diabetes and CKD. The study compared the effects of once-weekly semaglutide 1.0 mg injections versus a placebo. Findings revealed a 24% reduction in the risk of kidney disease worsening, kidney failure, and cardiovascular death in participants receiving semaglutide. Due to the overwhelming efficacy, the trial was stopped early after meeting its pre-specified criteria.

Expert Insights

Dr. Richard E. Pratley, Medical Director at the AdventHealth Diabetes Institute in Orlando, FL, and Co-Chair of the FLOW Trial, emphasized the significance of this approval:

“Managing type 2 diabetes is already challenging, and chronic kidney disease adds another layer of complexity. In my practice, I see many patients with serious kidney complications—some requiring dialysis. The FDA’s decision provides new hope and an additional treatment option that can make a meaningful difference in protecting kidney function and cardiovascular health.”

What This Means for Individuals with Diabetes and CKD

For individuals living with both type 2 diabetes and CKD, semaglutide offers a new treatment option to help preserve kidney function and lower the risk of life-threatening cardiovascular events. Effectively managing both conditions can improve long-term health outcomes and quality of life.

If you are working with individuals with type 2 diabetes and CKD, initiating semaglutide early in the treatment plan can not only protect kidney health but also decrease the risk of worsening kidney function, further improving outcomes.

Conclusion

The FDA’s expanded approval of Ozempic marks a crucial milestone for people with type 2 diabetes and CKD. With strong clinical trial evidence supporting its effectiveness, this treatment provides renewed hope for those at risk of worsening kidney disease and cardiovascular complications. 

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NEJM Article: Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes