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January 30, 2025 – The US Food and Drug Administration (FDA) has approved semaglutide (Ozempic, Novo Nordisk) for reducing the risk of worsening kidney disease and cardiovascular death in adults with both type 2 diabetes and chronic kidney disease (CKD). This latest approval marks a significant advancement in the treatment options available for patients managing these coexisting conditions.
Breakthrough Backed by Clinical Trial
The approval is based on the results of the international FLOW kidney outcomes trial, a phase 3b study involving over 3,500 individuals diagnosed with both CKD and type 2 diabetes. Participants were randomized to receive either once-weekly semaglutide or a placebo in addition to standard care.
The trial successfully met its primary endpoint, demonstrating a 24% relative risk reduction in kidney disease progression, end-stage kidney disease, and cardiovascular-related death among those receiving semaglutide 1 mg. Additionally, an absolute risk reduction of 4.9% over three years was observed compared to the placebo group.
Expanded Indications for Ozempic
Prior to this latest approval, Ozempic had been indicated for improving glycemic control in adults with type 2 diabetes and for reducing the risk of major cardiovascular events in those with pre-existing heart disease. With the new indication, Ozempic now offers an additional layer of protection for patients vulnerable to kidney disease progression and cardiovascular complications.
Expert Insights on FDA Decision
Dr. Richard E. Pratley, co-chair of the FLOW trial and medical director at the AdventHealth Diabetes Institute in Orlando, Florida, emphasized the importance of this decision in a statement from Novo Nordisk.
“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,” said Dr. Pratley.
He further noted that a substantial number of his patients suffer from severe kidney complications, with some requiring dialysis. He expressed optimism that the FDA’s decision offers new hope for millions of adults managing both conditions, representing a crucial step forward in patient care.
A Milestone in Diabetes and Kidney Disease Management
This latest approval expands the therapeutic landscape for individuals facing the dual burden of type 2 diabetes and CKD, providing physicians with an additional tool to mitigate risks associated with these conditions. As the medical community continues to explore new treatment strategies, this decision highlights the potential of semaglutide in addressing not only glycemic control but also broader renal and cardiovascular health concerns.
Disclaimer
This article is for informational purposes only and should not be construed as medical advice. Patients should consult their healthcare providers for personalized recommendations regarding the use of Ozempic or any other medication. The information provided is based on publicly available data, and readers are encouraged to refer to official sources for the latest updates.
