The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk's Ozempic (semaglutide) for reducing the risk of kidney disease worsening, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This approval marks a significant advancement in treating patients with these co-morbidities, as diabetes is a leading cause of kidney failure.
Clinical Trial Data
The FDA's decision was based on data from the Phase 3b FLOW trial, a randomized, double-blind, placebo-controlled study involving 3,533 adults with type 2 diabetes and CKD across 28 countries. The trial compared once-weekly Ozempic 1 mg to placebo, both added to standard care. The results demonstrated a statistically significant and superior 24% relative risk reduction in kidney disease worsening, kidney failure, and cardiovascular death with Ozempic compared to placebo (4.9% absolute risk reduction at 3 years).
Richard E. Pratley, MD, Medical Director at the AdventHealth Diabetes Institute Orlando, FL, and Co-Chair of the FLOW Trial, noted, "Type 2 diabetes can be challenging enough to manage without the added risk of chronic kidney disease... 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."
Impact and Implications
This approval expands Ozempic's label, making it the most broadly indicated glucagon-like peptide-1 receptor agonist (GLP-1 RA) in its class. Ozempic is now approved to improve glycemic control in adults with type 2 diabetes and reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease, in addition to its new indication for reducing kidney disease risks.
Anna Windle, PhD, Senior Vice President Clinical Development, Medical & Regulatory Affairs at Novo Nordisk, stated, "This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated."
Disease Burden and Current Treatment Landscape
CKD affects approximately 37 million adults in the U.S., with about 40% of people with type 2 diabetes also experiencing CKD. Diabetes is the leading cause of kidney failure, and CKD can significantly increase the risk of cardiovascular problems and death for people with type 2 diabetes. Current treatment options for CKD primarily focus on managing blood pressure, blood sugar, and cholesterol levels, but effective therapies to slow kidney disease progression have been limited.
Ongoing Research
Novo Nordisk is conducting further studies to understand the mechanisms by which semaglutide reduces the progression of kidney disease. While the exact mechanisms are not fully understood, the positive effects observed in clinical trials are significant, leading to the early termination of the FLOW trial due to efficacy.
