By Fineline Cube 
Novo Nordisk A/S (NYSE: NVO) announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has approved an update to the label of Rybelsus® (oral semaglutide), incorporating proven cardiovascular benefits demonstrated in the Phase 3b SOUL trial.
Key Highlights
- SOUL Trial – Enrolled patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) or chronic kidney disease (CKD).
- Cardiovascular Outcome – Oral semaglutide reduced major adverse cardiovascular events (MACE) by 14 % versus placebo.
- Label Update – Rybelsus is now the first and only orally‑administered GLP‑1 receptor agonist (GLP‑1 RA) in the EU with an evidence‑based cardiovascular benefit.
Market Impact
- Competitive Edge – The cardio‑protective labeling differentiates Rybelsus from other GLP‑1 RAs, potentially expanding its share in the €6 billion‑plus T2D market.
- US Expansion – A U.S. label extension for cardiovascular indication is expected later this year, aligning the two markets.
- Patient Reach – The oral formulation removes injection barriers, improving adherence for patients with ASCVD or CKD—a population at high cardiovascular risk.
Company Outlook
Novo Nordisk’s update underscores its commitment to evidence‑based diabetes care and positions the company at the forefront of cardiovascular‑centric endocrinology. The enhanced labeling is likely to strengthen prescriber confidence and accelerate uptake in both established and new markets.-Fineline Info & Tech