Novo Nordisk’s Ozempic Shows Promising Kidney Benefits for Diabetic Patients

1. Novo Nordisk's semaglutide (marketed as Ozempic) demonstrated significant reductions in the risk of cardiovascular events and death among patients with type 2 diabetes and chronic kidney disease during the Phase III FLOW trial.
2. Ozempic reduced the risk of kidney disease progression, major cardiac events, and death by 24% compared to a placebo.
3. The FLOW trial initially started in 2019 and included approximately 3,500 patients with diabetes and moderate to severe chronic kidney disease.
4. Due to positive results, the trial was stopped early in October 2023, ahead of schedule.
5. Novo Nordisk plans to present full data from the study later in 2024 and intends to seek expanded approval for Ozempic based on these findings in both the U.S. and Europe.
6. This development may strengthen the case for using Ozempic not only to manage blood sugar levels but also to reduce weight in individuals with Type 2 diabetes, given that about one-third of such patients develop chronic kidney disease.
7. Ozempic has previously received FDA approval as a preventative treatment for heart attacks and strokes, which are major causes of death and hospitalization in people with Type 2 diabetes.
8. The findings could potentially increase the competitive advantage of Ozempic over Eli Lilly's Mounjaro, which has not completed the necessary clinical trials to demonstrate similar benefits.
9. The FLOW trial's design required Ozempic to reduce the absolute risk of kidney-related conditions by at least 3.5% compared to placebo, or a relative risk reduction of around 16.5%.
10. The positive trial results may not increase the number of patients eligible to receive Ozempic, but they do strengthen the rationale for its use in the target population.