EMA Committee approves update to Novo Nordisk Rybelsus label to reflect cardiovascular benefits
Denmark: Novo Nordisk has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial.
SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsuson cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Rybelsus is now the oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit.
“Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk. “This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”
New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo. Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants.
In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus. Novo Nordisk has also submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide (Wegovy in a pill) in adults living with obesity or overweight and cardiovascular disease. A decision is expected at the turn of this year, and if approved, Wegovy would become the oral GLP-1 RA indicated for chronic weight management.
Rybelsus is an oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019.
