Novo Nordisk A/S: Ozempic® receives EU recommendation in peripheral arterial disease, cementing the broad benefits of semaglutide for people with type 2 diabetes and comorbidities

Core Viewpoint - Novo Nordisk has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding an update to the Ozempic label, reflecting positive data from the STRIDE trial for peripheral artery disease [1][3] Group 1: Product Updates - Ozempic (once-weekly semaglutide) is set to have the broadest approved label in the GLP-1 RA class, demonstrating improvements in blood sugar, weight, cardiovascular events, chronic kidney disease, and PAD functional outcomes [5] - The STRIDE trial showed a 13% improvement in maximum walking distance for patients with type 2 diabetes and symptomatic PAD compared to placebo [9] - Novo Nordisk has also filed for a label expansion for Rybelsus, which could make it the first oral GLP-1 RA with proven cardiovascular benefits [4][11] Group 2: Clinical Trial Insights - The STRIDE trial enrolled 792 participants and achieved its primary endpoint, demonstrating significant improvements in walking capacity [8] - The SOUL trial indicated a 14% risk reduction in major adverse cardiovascular events for Rybelsus compared to placebo [11] - The FLOW trial showed a 24% risk reduction in kidney disease progression for semaglutide compared to placebo [14] Group 3: Market Position and Impact - Ozempic is currently marketed in 72 countries, with 7 million people being treated worldwide [16] - Rybelsus is available in 45 countries, with over 2.1 million patients currently treated [17] - The positive outcomes from these trials position Novo Nordisk's products as leading options for managing type 2 diabetes and its associated complications [3][4]