DENMARK – Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide) has achieved a groundbreaking milestone as the first drug in its class approved by the FDA to reduce the risk of worsening kidney disease in individuals with type 2 diabetes.
This new indication complements its earlier approvals for managing type 2 diabetes and reducing cardiovascular risk in diabetic patients with heart disease.
Now, Ozempic is also authorized to prevent kidney disease progression, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD).
Anna Windle, Novo Nordisk’s head of clinical development, medical, and regulatory affairs, highlighted the significance of this approval, stating, “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.”
CKD affects around 37 million adults in the U.S. and is a common complication of diabetes, with roughly 40% of people with type 2 diabetes eventually developing the condition.
The FDA’s decision was based on data from the FLOW trial, which demonstrated the efficacy of a 1 mg weekly dose of Ozempic in significantly reducing kidney disease progression, kidney failure, and cardiovascular deaths.
After three years, the trial showed a 24% relative risk reduction in these outcomes compared to placebo when combined with standard care, with an absolute risk reduction of 4.9%.
This expanded indication bolsters Novo Nordisk’s position in the competitive GLP-1 agonist market, where its primary rival is Eli Lilly.
Lilly’s dual GIP/GLP-1 agonist, Mounjaro (tirzepatide), currently competes in diabetes and obesity markets and is undergoing a phase 3 trial (TREASURE-CKD) for CKD treatment in obese individuals, with or without diabetes.
Both Ozempic, marketed as Wegovy for obesity, and Lilly’s Zepbound are battling for dominance in the obesity category as well.
Ozempic has proven its market strength, generating over US $12 billion in global sales in the first nine months of 2024, compared to Lilly’s US $8 billion from Mounjaro during the same period.
Novo Nordisk is also exploring additional indications for semaglutide, including metabolic dysfunction-associated steatohepatitis (MASH) and Alzheimer’s disease.
The increasing prevalence of obesity and its associated complications, including type 2 diabetes and CKD, has created a pressing need for innovative therapies.
CKD and diabetes elevate the risks of kidney dysfunction and cardiovascular issues, while obesity independently contributes to kidney damage through mechanisms like inflammation, oxidative stress, and increased kidney pressure.
While existing treatments, such as renin-angiotensin system (RAS) inhibitors and sodium-glucose co-transporter 2 (SGLT2) inhibitors, have helped manage these conditions, the high residual risk underscores the demand for more comprehensive solutions.
Semaglutide has emerged as a promising therapy, addressing both weight loss and kidney health through its ability to regulate appetite, improve glucose control, and reduce kidney inflammation.
The FLOW trial also revealed broader benefits for participants, with many experiencing reduced hunger and significant weight loss.
Although the study did not evaluate long-term lifestyle changes, it underscored semaglutide’s potential to improve overall health outcomes.
However, the unprecedented demand for semaglutide, driven by its weight loss benefits, has resulted in global shortages, complicating efforts to expand its clinical applications.