Ozempic adds indication for patients with diabetes and CKD

Showed a 24% reduction in the risk of renal composite endpoint compared to placebo

Novo Nordisk

Novo Nordisk Korea (General Manager: Kasper Roseeuw Poulsen) announced on the 28th that Ozempic has been approved as a treatment for type 2 diabetes with chronic kidney disease.

 

With this approval, Ozempic is now indicated for: ▲ Use as an adjunct to a two-drug regimen (either alone or in combination with other diabetes medications), in adults with type 2 diabetes whose condition is not adequately controlled.

 

▲Reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and confirmed cardiovascular disease.

 

This approval expands its indications to encompass the broadest patient base among GLP-1 receptor agonist (GLP-1RA) type 2 diabetes treatments launched in Korea.

 

Ozempic has further solidified its position as a comprehensive treatment option for adult patients with type 2 diabetes, not only offering glycemic control but also a reduction in the risk of major adverse cardiovascular events (MACE), sustained reduction in estimated glomerular filtration rate (eGFR) in adults with type 2 diabetes and chronic kidney disease, and reduction in the risk of reaching end-stage kidney disease and cardiovascular disease mortality.

 

The expansion of Ozempic's indication to chronic kidney disease was based on results from the FLOW study.

 

The FLOW study was a multinational, multicenter, placebo-controlled, double-blind, 1:1 randomized study evaluating the efficacy and safety of Ozempic versus placebo in 3,533 adult patients with type 2 diabetes and chronic kidney disease.

 

The primary endpoint of this study was a composite endpoint consisting of a sustained 50% or greater decline in estimated glomerular filtration rate (eGFR) from baseline, occurrence of end-stage kidney disease, or death due to cardiovascular or renal disease.

 

The median follow-up period was 3.4 years, and the Ozempic group demonstrated a 24% reduction in the risk of the composite endpoint compared to the placebo group.

 

Furthermore, serious adverse events reported in this study occurred in 877 patients (49.6%) in the Ozempic group and 950 patients (53.8%) in the placebo group, showing similar rates between the two groups.

 

Kasper Roseeuw Poulsen, General Manager of Novo Nordisk Korea, stated, “The expansion of Ozempic's indication for chronic kidney disease marks a turning point, signaling that diabetes treatment has entered a new era where treatment goes beyond simple blood glucose control to comprehensive management of cardiovascular and renal risks.

 

“As a company that has led diabetes care for over 100 years, Novo Nordisk is setting new standards in type 2 diabetes treatment based on its scientific innovation and accumulated experience.

 

Moving forward, Novo Nordisk will continue to serve as a trusted partner for patients and healthcare professionals across all areas of diabetes care, and lead the future of integrated treatment in diabetes.”