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 IIIb trial conducted to assess the effect of Rybelsus on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).
Rybelsus reduced cardiovascular death, heart attack and stroke by 14% versus placebo when added to standard of care.
The oral semaglutide is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) available in the EU for type 2 diabetes that also has a proven cardiovascular benefit.
Emil Kongshøj Larsen, Executive Vice President, International Operations at Novo Nordisk, said: “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."
“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, taking place on the 15–19 September.
These will include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events when compared with a placebo.
Additional SOUL results will be presented at the meeting, which highlight that the cardiovascular benefits of oral semaglutide are consistent regardless of both 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 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 first oral GLP-1 RA indicated for chronic weight management.
Launched in 2019, Rybelsus is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes.
It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes.