The Food and Drug Administration (FDA) approved Novo Nordisk’s Ozempic on January 28, 2025, for treating chronic kidney disease in adults with Type 2 diabetes. This approval expands the drug’s use in the U.S., allowing it to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in affected patients.
- FDA approves Ozempic for chronic kidney disease
- Ozempic reduces kidney failure and cardiovascular death
- Diabetes increases risk of chronic kidney disease
- Ozempic improves kidney function and cardiovascular health
- Trial results led to early approval decision
- Novo Nordisk faces competition from Eli Lilly
This decision could significantly change treatment approaches for chronic kidney disease, which affects approximately 37 million American adults. Diabetes is a major risk factor for this condition, with about 40% of Type 2 diabetes patients also experiencing kidney disease.
Chronic kidney disease (CKD) is a progressive condition characterized by a gradual decline in kidney function. It is one of the leading causes of death in the U.S. The recent FDA approval of Ozempic highlights its benefits beyond diabetes management, as it can also significantly reduce severe kidney outcomes by 24% compared to a placebo in patients with both diabetes and CKD.
Key statistics from the late-stage trial supporting the FDA’s decision include:
- Kidney function decline was slower in patients taking Ozempic.
- The risk of major cardiovascular events decreased by 18%.
- The risk of death from any cause fell by 20%.
- Cardiovascular-related deaths decreased by 29%.
Stephen Gough, Novo Nordisk’s global chief medical officer, emphasized the interconnection between chronic kidney disease and cardiovascular issues, noting that effective treatments addressing both conditions can significantly improve patient outcomes. The approval also follows the company’s successful phase three trial, which concluded early due to positive results.
This FDA approval marks a significant milestone for Ozempic, reinforcing its role not only in managing diabetes but also in addressing critical health risks associated with chronic kidney disease. As Novo Nordisk faces increased competition in the diabetes treatment market, this development may enhance its position and influence treatment protocols for patients with multiple comorbidities.
