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Novo Nordisk's Rybelsus gains EU approval for cardiovascular benefits, enhancing treatment options for type 2 diabetes and improving patient outcomes.
The EU approved an update to Rybelsus’ label reflecting its recent Phase III clinical trial results showing positive cardiovascular benefits.
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Novo Nordisk announced the European Medicines Agency’s Committee for Medicinal Products for Human Use approved an update for Rybelsus’ label now displaying its cardiovascular benefits discovered in the Phase 3b SOUL trial.
“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. Larsen continued, saying,“This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”
Novo Nordisk is planning on sharing the full results from the GLP-1’s Phase 3b SOUL trial later this week at the European Association for the Study of Diabetes’ (EASD) 2025 Annual Meeting, running from September 15-19. The presentation is expected to include findings displaying how patient treatment with oral semaglutide significantly reduces hospitalizations for serious adverse events compared with placebos. Additional results from the Phase 3b SOUL trail will also be presented during the meeting, emphasizing the cardiovascular benefits of oral semaglutides and their consistency of production, regardless of the patient’s body mass index or body weight.
As for Rybelsus’s approval in the U.S., a decision is expected to be announced later this year, regarding its label update for cardiovascular benefits. As of now, Novo Nordisk has submitted an application for a daily 25mg oral formulation of Wegovy, for adults who are overweight or living with obesity, along with those suffering from cardiovascular disease. The decision on Wegovy’s application is expected by the end of the year.
Rybelsus a glucagon-like peptide 1 receptor agonist, (GLP-1 RA) is indicated for treatment of adults with type 2 diabetes mellitus, which improves glycaemic control. Rybelsus offers improved blood glucose lowering effects, compared to placebo and other generic GLP-1s, along with consistent weight reduction, reduction in cardiometabolic risk factors, and reduction in major adverse cardiovascular events (MACE).1 Rybelsus currently is available in 48 countries and is administered as a treatment for more than 2.4 million people diagnosed with type 2 diabetes worldwide.
Phase 3b SOUL trial
The Phase 3b SOUL trial was a multicenter, international, randomized, double-blind, parallel-group, placebo-controlled, Phase III cardiovascular outcomes trial, including 9,650 participants in the study.2 The study aimed to assess the effects of oral semaglutide compared to placebo, when added to the standard of care for cardiovascular events in patients diagnosed with type 2 diabetes along with established cardiovascular disease and/or chronic kidney disease (CKD). Results from the SOUL trial displayed superior reductions in MACE for 14% of patients treated with oral semaglutide compared to placebo in patients with type 2 diabetes, cardiovascular disease and/or CKD.
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