The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks associated with chronic kidney disease (CKD).
The Danish drugmaker’s popular weight loss medication is now indicated to reduce the risk of kidney failure and disease progression, as well as death due to cardiovascular disease. Type 2 diabetes (T2D) patients with CKD will be eligible for the approval.
The new indication makes Ozempic the first glucagon-like peptide-1 receptor agonist (GLP-1RA) available for people with T2D and CKD. Novo Nordisk said its drug is the “most broadly indicated” GLP-1RA in its class.
Novo Nordisk’s clinical development, medical and regulatory affairs senior vice president Anna Windle said: “This approval for Ozempic allows us to more broadly address conditions within the cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated.”
Ozempic gained a similar label expansion last month when the European Medicines Agency (EMA) approved a new indication for the risk of events related to CKD.
CKD affects around 37 million adults in the US and is expected to rise in line with diabetes prevalence. The disease is common in patients with diabetes, as high blood sugar can damage blood vessels in the kidneys and nephrons. Around 40% of diabetes patients will develop CKD, leading to additional symptoms such as cardiovascular problems.
The FDA’s approval was based on results from the Phase IIIb FLOW study (NCT03819153) evaluating Ozempic in adults with T2D and CKD. The therapy helped reduce the risk of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease by 24% compared to a placebo.
Across the 3,533 patients who enrolled in the trial, kidney function declined more slowly and the risk of major cardiovascular events such as heart attack dropped by 18%. The drug also cut the risk of cardiovascular-related deaths by 29% and the risk of death from any cause by 20%.
As per its FDA label, Ozempic is also indicated to reduce the risk of major adverse cardiovascular events in adults with T2D and established heart disease.
Novo Nordisk is eyeing up further indications for its blockbuster drug such as a potential treatment for metabolic dysfunction-associated steatohepatitis (MASH) and Alzheimer’s. The company has reported positive results showing Ozempic’s ability to reduce liver and fat scarring in MASH patients, as well as the risk of Alzheimer’s diagnosis.
Ozempic generated $13.9bn in global sales for Novo Nordisk in 2023. The drug is forecast to reach $23.9bn in sales by 2030, according to GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
