- EMA's CHMP approves Rybelsus® label update for cardiovascular benefits.
- SOUL trial evaluated Rybelsus® in type 2 diabetes with ASCVD and/or CKD.
- New SOUL results to be shared at EASD 2025 Annual Meeting, 15–19 September.
- US decision on Rybelsus® cardiovascular label extension expected later this year.
EMA Approval
The European Medicines Agency's Committee for Medicinal Products for Human Use has approved an update to the Rybelsus® label, reflecting its cardiovascular benefits as demonstrated in the SOUL trial. This makes Rybelsus® the first oral GLP-1 receptor agonist in the EU with proven cardiovascular benefits for type 2 diabetes patients.
SOUL Trial Findings
The SOUL trial, a phase 3b study, assessed the impact of Rybelsus® on cardiovascular outcomes in individuals with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease. Results showed significant reductions in hospitalizations related to serious adverse events compared to placebo. The cardiovascular benefits were consistent across different body mass index and weight categories.
Upcoming Presentations
New findings from the SOUL trial will be presented at the European Association for the Study of Diabetes 2025 Annual Meeting, scheduled for 15–19 September. These presentations will provide further insights into the cardiovascular benefits of oral semaglutide.
US Regulatory Developments
In the United States, a decision on extending the Rybelsus® label for cardiovascular indications is anticipated later this year. Additionally, Novo Nordisk has submitted an application for a once-daily 25 mg oral formulation of semaglutide, known as Wegovy®, for adults with obesity or overweight and cardiovascular disease. A decision on this application is expected by the end of the year.
