EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke

Core Viewpoint - Novo Nordisk's Rybelsus (oral semaglutide) has received approval from the European Medicines Agency (EMA) for an updated label reflecting cardiovascular benefits demonstrated in the SOUL trial, making it the first oral GLP-1 receptor agonist with proven cardiovascular benefits for type 2 diabetes in the EU [1][6][8] Group 1: Product Approval and Clinical Trial Results - The SOUL trial, a phase 3b study with 9,650 participants, showed a 14% reduction in major adverse cardiovascular events (MACE) for those treated with oral semaglutide compared to placebo [5][6] - New results from the SOUL trial will be presented at the EASD 2025 Annual Meeting, indicating significant reductions in hospitalizations related to serious adverse events for oral semaglutide compared to placebo [2][8] - Rybelsus is now recognized as the only oral GLP-1 RA with proven cardiovascular benefits, alongside its established efficacy in blood glucose and body weight reduction [4][6][8] Group 2: Future Developments and Market Position - A decision regarding a label extension for Rybelsus in the US is anticipated later this year, which may further enhance its market position [3] - Novo Nordisk has submitted an application for a once-daily 25 mg oral formulation of semaglutide (Wegovy) for adults with obesity or overweight and cardiovascular disease, with a decision expected soon [3] - Rybelsus is currently available in 48 countries, with over 2.4 million patients being treated worldwide, highlighting its significant market presence [8]