Novo Nordisk's Rybelsus Shows Promise in Reducing Cardiovascular Events
Copenhagen, Saturday, 29 March 2025.
Novo Nordisk’s Rybelsus reduced major cardiovascular events by 14% in type 2 diabetes patients, as revealed in the SOUL trial at ACC 2025.
Groundbreaking Trial Results
Novo Nordisk A/S (NYSE: NVO) presented the landmark SOUL trial results at the American College of Cardiology’s Annual Scientific Session in Chicago on March 29, 2025, demonstrating that Rybelsus® significantly reduces cardiovascular risks in type 2 diabetes patients [1]. The trial, which enrolled 9,650 participants, showed that oral semaglutide 14 mg reduced major adverse cardiovascular events by 14% compared to placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease [1][2].
Clinical Significance
The SOUL trial’s findings are particularly significant as Rybelsus® stands as the only approved oral GLP-1 medicine demonstrating cardiovascular risk reduction when added to standard care [1]. ‘Heart attacks and strokes are the leading causes of disability and death for people with type 2 diabetes,’ emphasized Dr. Darren McGuire, Distinguished Chair in Cardiovascular Science at UT Southwestern and SOUL steering committee co-chair [2]. Currently, more than 2.1 million people with type 2 diabetes worldwide are being treated with Rybelsus® [1].
Regulatory Implications
Based on these compelling results, Novo Nordisk has submitted a label extension application to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for cardiovascular event risk reduction [1]. Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, highlighted that this development represents the company’s strategic evolution ‘beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health’ [2].
Market Impact and Future Outlook
The timing of this breakthrough is crucial, as Rybelsus® is currently marketed in 45 countries [2]. The medication has demonstrated superior blood glucose lowering and consistent weight reduction compared to other diabetes treatments [1]. A regulatory decision on the label extension is anticipated later in 2025 [1], which could potentially expand the therapeutic applications of this oral medication [alert! ‘exact decision date not specified in sources’].