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FDA expands Ozempic's use for kidney, heart protection
Novo Nordisk's Ozempic gains FDA approval for kidney and heart protection in type 2 diabetes patients with chronic kidney disease, reinforcing its role in cardiometabolic care.
Novo Nordisk has secured a key FDA approval for its widely used diabetes drug, Ozempic, i.e., semaglutide. This approval expands its indication to include reducing kidney disease progression, kidney failure and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. This latest approval strengthens Ozempic's position as the most broadly indicated glucagon-like peptide-1 receptor agonist on the market, highlighting a shift in diabetes treatment beyond blood sugar control.
GLP-1 RAs in chronic disease management
The FDA's decision is backed by data from the FLOW Phase 3b trial, which demonstrated a 24% reduction in the risk of kidney disease worsening, kidney failure and cardiovascular death compared to placebo. With chronic kidney disease (CKD) affecting around 37 million U.S. adults -- 40% of whom also have type 2 diabetes -- this approval addresses a significant unmet need.
For the pharmaceutical industry, the move underscores a growing trend toward treating diabetes holistically, factoring in cardiovascular and renal risks rather than focusing solely on glycemic control. The expanded label could shift prescribing patterns, making glucagon-like peptide-1 receptor agonists (GLP-1 RAs) a key player in managing diabetes-related complications and broadening their use across multiple specialties, including nephrology and cardiology.
Market impact
With this new approval, Novo Nordisk gains a competitive edge in the increasingly crowded GLP-1 RA market. While other drugs in this class have demonstrated cardiovascular benefits, Ozempic is now the only GLP-1 RA with explicit FDA approval for kidney protection in type 2 diabetes patients.
This move is likely to put pressure on competitors, particularly Eli Lilly's Mounjaro (tirzepatide), which is being studied for similar benefits. The market for cardiometabolic therapies is evolving rapidly, and pharmaceutical companies will likely accelerate research into additional indications and combination treatments to maintain a competitive edge.
Impact on payers and providers
Novo Nordisk's expanded indication also raises questions about insurance coverage and reimbursement. Historically, GLP-1 RAs have been covered primarily for diabetes management rather than cardiovascular or renal benefits. However, with growing clinical evidence showing long-term cost savings by preventing complications, insurers might be pushed to reconsider their formularies.
The approval could also shift providers' prescribing habits. Nephrologists, who have traditionally relied on sodium-glucose co-transporter-2 (SGLT2) inhibitors for kidney protection in diabetes patients, might now consider Ozempic as part of their treatment arsenal. Given the drug's added cardiovascular benefits, cardiologists might also take note.
The future of diabetes and CKD care
Novo Nordisk's continued push into cardiometabolic care reflects a broader industry trend: As diabetes, kidney disease and cardiovascular issues become increasingly interconnected in treatment paradigms, pharmaceutical companies are likely to invest further in multifunctional therapies.
Ozempic's new approval could prompt updates to clinical guidelines and treatment protocols, influencing how diabetes-related kidney disease is managed in both primary care and specialty settings. Real-world data will be key in determining how the drug performs outside clinical trials and whether it influences long-term outcomes for millions of patients.
With chronic disease management becoming more integrated, the FDA's latest decision signals a new chapter for GLP-1 RAs.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
