India Pharma Outlook Team | Tuesday, 16 September 2025
Novo Nordisk's Rybelsus (oral semaglutide) received an updated label from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in a significant regulatory victory, based on evidence of cardiovascular benefit from the SOUL trial.
The 387-participant phase 3b SOUL study examined Rybelsus among adults with type 2 diabetes with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). SOUL found a 14% reduction in major adverse cardiovascular events (i.e., cardiovascular-related death, heart attacks, and stroke) in patients taking Rybelsus when compared with patients taking placebo.
Rybelsus is now the first and only oral GLP-1 receptor agonist in the EU approved to support weight reduction when prescribed for patients with type 2 diabetes who also have proven cardiovascular benefit. Rybelsus also already has established clinical and real-world evidence for its efficacy in reducing blood sugar and weight.
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“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.
Novo Nordisk states additional SOUL trial data, specifically regarding hospitalization reductions, will be released later this week at EASD-2025. At the same time, the company has filed applications with the U.S. Regulatory Authority for a cardiovascular indication extension for Rybelsus and for a once-daily 25 mg oral formulation of semaglutide for chronic weight management in adult patients with obesity or overweight and cardiovascular disease. Decisions on the U.S. applications are expected later this year.
