Novo Nordisk A/S: Rybelsus® (oral semaglutide 14 mg) demonstrates superior reduction in cardiovascular events in the SOUL trial at ACC 2025

Core Insights - Novo Nordisk's Rybelsus (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events (MACE) by 14% in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD) compared to placebo [2][7][8] - The SOUL trial, a phase 3b study, involved 9,650 participants and confirmed the cardiovascular benefits of Rybelsus, which is the only approved oral GLP-1 medicine [8][9] - Novo Nordisk has submitted a label extension application for Rybelsus to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for cardiovascular event risk reduction, with a decision expected in 2025 [6][7] Company Focus - Novo Nordisk is expanding its focus beyond diabetes and obesity to encompass a broader spectrum of metabolic and cardiovascular health, reinforcing its leadership in this area [4] - The company emphasizes the importance of patient-centric treatments to manage cardiovascular risks associated with type 2 diabetes [3] Clinical Trial Details - The SOUL trial achieved its primary endpoint, demonstrating a significant reduction in MACE, which includes cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke [2][8] - The safety profile of Rybelsus in the SOUL trial was consistent with previous studies, showing a lower incidence of serious adverse events compared to placebo [4][5] Market Position - Rybelsus is currently marketed in 45 countries, with over 2.1 million patients being treated worldwide, highlighting its significant market presence [9]