European Medicines Agency (EMA) official announcements

Novo Nordisk's Rybelsus Cuts Cardiovascular Risk by 14% in SOUL Trial

Oct 21, 2024, 10:15 AM

Novo Nordisk's oral semaglutide, marketed as Rybelsus, has demonstrated a 14% reduction in the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes, according to the results of the SOUL trial. The late-stage study, announced on Monday, involved over 9,600 patients with type 2 diabetes and heart or kidney disease. Novo Nordisk plans to file for regulatory approval of a label expansion for Rybelsus in both the US and EU around the turn of the year. The drug, a tablet version of Ozempic, showed significant potential in reducing the risk of heart attacks and strokes, which may drive broader use of the medication.