Novo Nordisk Achieves EU Approval For Oral Semaglutide, The First And Only Oral GLP-1 RA to Reduce Cardiovascular Death, Heart Attack, And Stroke

Novo Nordisk has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus (oral semaglutide) label to include information about its cardiovascular benefits demonstrated in the SOUL trial. SOUL was a phase 3b study designed to evaluate the effects of Rybelsus on cardiovascular outcomes in adults with type 2 diabetes who also had atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). 

With this update, Rybelsus becomes the first and only oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) available in the European Union that has a proven benefit for heart health in addition to controlling blood sugar. GLP-1 RAs mimic a natural hormone in the body that helps regulate blood sugar, appetite, and digestion.

Emil Kongshøj Larsen, executive vice president of International Operations at Novo Nordisk, highlighted the importance of this approval, stating that heart problems are a leading cause of disability and death in people with type 2 diabetes. He explained that therapies addressing both diabetes and cardiovascular health can improve patient outcomes and quality of life, and this approval is an important milestone in achieving that goal.

Additional results from the SOUL trial will be presented later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, taking place from September 15 to 19. These include data showing that treatment with oral semaglutide significantly reduced hospitalizations due to serious adverse events compared with placebo. Other findings to be shared at the same meeting will show that the cardiovascular benefits of oral semaglutide were consistent across participants, regardless of their body mass index (BMI) or body weight.

In the United States, the Food and Drug Administration (FDA) is expected to make a decision later this year on extending the Rybelsus label to include cardiovascular benefits. Novo Nordisk has also applied in the U.S. for approval of a once-daily 25 mg oral formulation of semaglutide, marketed as Wegovy in its injectable form, for adults with obesity or overweight who also have cardiovascular disease. A decision on this application is anticipated around the end of the year. If approved, Wegovy would become the first oral GLP-1 RA available for chronic weight management.

Rybelsus was first approved in 2019 as the only oral GLP-1 RA for type 2 diabetes. Since then, it has been supported by strong clinical and real-world evidence demonstrating its ability to reduce blood glucose levels and body weight more effectively than multiple other treatments, while maintaining an established safety profile for people with type 2 diabetes.