The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the label of Novo Nordisk’s oral diabetes drug Rybelsus (oral semaglutide) to include cardiovascular benefits demonstrated in the recent SOUL trial.
With this decision, Rybelsus becomes the first and only oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the EU shown to reduce the risk of cardiovascular events—including heart attack, stroke, and cardiovascular death—in adults with type 2 diabetes and established cardiovascular or kidney disease.
The phase 3b SOUL trial evaluated the effect of oral semaglutide on major adverse cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). The study demonstrated that Rybelsus® not only manages blood glucose and supports weight loss but also provides significant cardiovascular protection.
“Heart problems are the leading cause of disability and death for people living with type 2 diabetes,” said Emil Kongshøj Larsen, executive vice president for International Operations at Novo Nordisk. “This approval is a milestone that underscores the unique position of semaglutide as the only oral GLP-1 RA delivering both glycaemic control and cardiovascular benefit.”
Further findings from the SOUL trial, to be presented this week at the European Association for the Study of Diabetes (EASD) Annual Meeting, revealed that oral semaglutide significantly reduced hospitalisations due to serious adverse events compared to placebo. Importantly, the cardiovascular benefits were found to be consistent across different body mass index (BMI) categories and weight levels.
In the United States, a decision on a similar label extension for Rybelsus is expected later this year. Novo Nordisk has also submitted an application to the U.S. FDA for a new 25 mg oral formulation of semaglutide, marketed under the brand Wegovy, for chronic weight management in adults with obesity or overweight and cardiovascular disease.
First approved in 2019, Rybelsus remains the only oral GLP-1 RA available for the treatment of type 2 diabetes. Its efficacy in reducing blood sugar and body weight, combined with a growing body of evidence for cardiovascular protection, strengthens its role in modern diabetes care.