Novo Nordisk received approval from the FDA for Ozempic in chronic kidney disease in patients who also have Type 2 diabetes to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease. Diabetes is a key risk factor for kidney disease. Approximately 40% of Type 2 diabetes patients have chronic kidney disease (CKD).

The approval is based on results from the Phase III FLOW trial demonstrating Ozempic reduced the risk of severe kidney outcomes by 24% compared to placebo, including kidney failure, reduction in kidney function, or death from kidney or heart causes, in diabetic patients with chronic kidney disease.

Additionally, in patients who took Ozempic, kidney function declined more slowly, the risk of major cardiovascular events such as heart attack dropped 18% and the risk of death from any cause fell 20% compared with the placebo. Ozempic also reduced the risk of cardiovascular-related deaths by 29%.

The rate of serious adverse side effects was 49.6% in patients who took Ozempic and 53.8% in the placebo group. There was a slightly higher rate of discontinuations among Ozempic patients due to gastrointestinal side effects, such as nausea and vomiting.

FLOW was an international, randomized, double-blind, parallel-group, placebo-controlled, event-driven superiority trial comparing injectable semaglutide 1 mg with placebo as an adjunct to standard of care on kidney outcomes for reducing the risk of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and CKD.