"Novo Nordisk has received approval from the U.S. Food and Drug Administration (FDA) for Ozempic® (semaglutide) to reduce the risk of worsening kidney disease, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease (CKD).
Chronic kidney disease is a serious condition affecting approximately 37 million adults in the United States, with type 2 diabetes being a leading cause.
It is estimated that around 40% of individuals with type 2 diabetes also develop CKD, which significantly increases the risk of further complications, including cardiovascular problems and premature death.
The approval provides a new treatment option for patients facing these dual health challenges.
This latest approval extends the existing indications of the glucagon-like peptide-1 receptor agonist (GLP-1 RA), which is already used to improve blood sugar control and reduce the risk of major cardiovascular events in individuals with type 2 diabetes and established heart disease.
The decision is based on findings from the FLOW phase 3b trial, which examined the effects of weekly Ozempic® injections on kidney and cardiovascular outcomes in patients with type 2 diabetes and CKD.
The trial demonstrated a statistically significant 24% relative reduction in the risk of disease progression, kidney failure, and cardiovascular-related death when compared to a placebo, in addition to standard care. After three years, an absolute risk reduction of 4.9% was observed.
Initially approved in 2017 for improving blood sugar levels in adults with type 2 diabetes, Ozempic® received an additional indication in 2020 for reducing the risk of major cardiovascular events, such as heart attack and stroke, in patients with pre-existing heart disease.
The latest approval further expands its role in managing complications related to type 2 diabetes and CKD, offering an additional treatment option to improve patient outcomes.
As the prevalence of CKD continues to rise due to ageing populations and increasing diabetes cases, this development marks an important step in addressing a significant unmet medical need.