Novo Nordisk recently announced positive results from the kidney outcomes trial FLOW, in which Ozempic (semaglutide) 1.0mg reduced the risk of kidney disease progression and the risk of kidney and cardiovascular deaths by 24%. If approved, Ozempic will become the first glucagon-like peptide-1 (GLP-1) therapy option for patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The drug potentially fills an unmet need in the kidney disease space as it has an alternate mechanism of action to the current standard of care (SOC) in CKD, says GlobalData, a leading data and analytics company.

FLOW was a randomized, double-blind, placebo-controlled, parallel-group, Phase III trial to assess the safety and efficacy of semaglutide when added to SOC; 3,533 participants with T2D and CKD were enrolled and the safety and tolerability profiles were consistent with previous semaglutide 1.0mg studies.

Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments: “According to key opinion leaders (KOLs) interviewed by GlobalData, Ozempic could be an excellent option for patients who are diabetic and obese. In addition, KOLs believe that Ozempic has the potential to be a treatment option for non-diabetic CKD patients whose kidney problems are due to their obesity as opposed to diabetes.”

Ozempic is a GLP1 receptor agonist and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is formulated as an injectable solution for the subcutaneous route of administration.

Jaddoo concludes: “The aging global population will lead to an increase in the prevalence of CKD, leading to an expansion of the market as well as a growing need for more therapeutic options. However, the widespread use of generic CKD drugs continues to make it difficult for high-priced branded therapies to fully penetrate the market.”