- Demonstrated a 24% reduction in the risk of 바카라사이트 비타임 composite outcomes compared to placebo
- With approved indications for glycemic control and for reducing cardiovascular and kidney disease risks, Ozempic® expands its position as a comprehensive treatment option for adults with type 2 바카라사이트 비타임
[by Yu, Suin] Novo Nordisk Pharma Korea, Ltd. announced that on August 28, the Ministry of Food and Drug Safety (MFDS) approved an expansion of indications for Ozempic® (Semaglutide; “Ozempic®”), a glucagon-like peptide-1 receptor agonist (GLP-1RA) class type 2 diabetes treatment, to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, progression to kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).
In South Korea, diabetic kidney disease has been reported to affect about 1 in 4 (25.4%) patients aged 30 years or older with type 2 diabetes. Diabetic kidney disease is an independent risk factor for cardiovascular morbidity and mortality, requiring intensive management of diabetes and comorbidities.
With this approval, Ozempic® has become a broadly indicated GLP-1 receptor agonist available in Korea, following its prior approvals for improving glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise, used alone or with other antidiabetic medications, and reducing the risk of major adverse cardiovascular events (MACE[1]) in adults with type 2 diabetes and known heart disease. Ozempic® has further strengthened its position as a comprehensive treatment option for adult patients with type 2 diabetes by addressing not only glycemic control but also reducing the risk of major adverse cardiovascular events (MACE*), mitigating sustained eGFR decline, reducing the risk of progression to kidney failure (end-stage kidney disease), and lowering the risk of cardiovascular mortality in adults with type 2 diabetes and chronic kidney disease.
This approval for the expansion of indications for Ozempic® to include CKD is based on the global Flow trial. The Flow trial was an international, multicenter, placebo-controlled, double-blind, randomized (1:1) study that compared the efficacy and safety of Ozempic® to placebo in 3533 adults with type 2 diabetes and CKD.
In the study, the primary composite endpoint was defined as the occurrence of a sustained decline of ≥50% in eGFR from baseline, onset of end-stage kidney disease, or death due to cardiovascular or kidney disease. Over a median follow-up period of 3.4 years, Ozempic® demonstrated a 24% reduction in the risk of the composite endpoint compared to placebo (HR, 0.76; 95% CI, 0.66–0.88; p=0.0003). In addition, serious adverse events were reported in 877 patients (49.6%) in the Ozempic® group and 950 patients (53.8%) in the placebo, with similar rates observed between the two groups.
Kasper Roseeuw Poulsen, General Manager of Novo Nordisk Pharma Korea, stated, “This expansion of indications for Ozempic® to include chronic kidney disease is a significant advancement that demonstrates we have entered a new era in which diabetes treatment must address not only blood glucose control, but also the risk of cardiovascular disease and kidney disease.” He continued, “As a leader in diabetes treatment for more than 100 years, Novo Nordisk is establishing a new standard for type 2 diabetes treatment through scientific innovation and experience in diabetes care. Novo Nordisk will continue to be a trusted partner for patients and healthcare professionals, leading the future of advanced comprehensive approaches to treatment.”