“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,” says 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.”

The SOUL trial

SOUL was a phase 3b trial carried out to evaluate 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 is now the first and only 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, states Novo Nordisk.

A decision in the Us expected later this year

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 first oral GLP-1 RA indicated for chronic weight management.