Overview

• Rybelsus becomes the first and only oral GLP‑1 receptor agonist in the European Union with a proven cardiovascular benefit on its label.
• The CHMP update is based on SOUL, a phase 3b outcomes trial in about 9,650 participants that measured a composite of cardiovascular death, non‑fatal heart attack, and stroke.
• Additional SOUL analyses will be presented at the EASD 2025 meeting, including reduced hospitalisations related to serious adverse events and benefits consistent across body mass index categories.
• A U.S. FDA decision on adding a similar cardiovascular indication to Rybelsus is expected later this year, with a separate application for a once‑daily 25 mg oral semaglutide for weight management awaiting a decision around year‑end.
• Novo Nordisk shares traded higher after the EU label expansion was announced.