The U.S. Food and Drug Administration (FDA) has approved Ozempic® (semaglutide) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval is based on the results of the FLOW phase 3b trial, which demonstrated a 24% relative risk reduction in kidney disease progression, kidney failure, and cardiovascular death compared to placebo.
Chronic kidney disease affects approximately 37 million adults in the U.S., with type 2 diabetes being a leading cause. This new indication for Ozempic® offers a significant advancement in the treatment of patients managing both conditions.
Originally approved in 2017 for improving blood sugar control in type 2 diabetes, Ozempic® received an additional indication in 2020 to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease. With this latest approval, Ozempic® becomes the first GLP-1 receptor agonist indicated for reducing the risk of kidney disease progression and cardiovascular death in this patient population.
Dr. Richard Pratley, Medical Director at the AdventHealth Diabetes Institute in Orlando and co-chair of the FLOW trial, emphasized the importance of this development, stating that patients with type 2 diabetes and CKD "need extra support from medications that may have a profound clinical impact by lowering the risk of major kidney and cardiovascular outcomes."
Meanwhile, Eli Lilly’s tirzepatide, another GLP-1 receptor agonist, is currently being studied for its potential in chronic kidney disease. If successful, this could provide another treatment option and further expand the role of GLP-1 therapies in managing the complex needs of patients with type 2 diabetes and CKD.
With Ozempic® leading the way and promising developments from competitors like Eli Lilly's tirzepatide on the horizon, the future of CKD and diabetes care is positive.
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