Workflow
里程碑!司美格鲁肽片欧盟获批,诺和诺德押注心血管千亿美元市场

Core Viewpoint - Novo Nordisk announced that the European Medicines Agency (EMA) has approved an update to the label of Rybelsus (oral semaglutide) to reflect cardiovascular benefits demonstrated in the SOUL trial [2][4]. Group 1: Cardiovascular Benefits - Oral semaglutide is now the first oral GLP-1 receptor agonist in the EU to have confirmed cardiovascular benefits in the treatment of type 2 diabetes [4]. - The SOUL trial is a Phase 3b study assessing the impact of oral semaglutide on cardiovascular outcomes in patients with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD) [2][6]. Group 2: Implications for Treatment - Cardiovascular complications are a leading cause of disability and death among type 2 diabetes patients, making treatments that protect the heart crucial for improving health outcomes and quality of life [6]. - With this approval, semaglutide becomes the only oral GLP-1 RA that can lower blood sugar and weight while providing cardiovascular benefits [6]. Group 3: Future Developments - In the U.S., a decision regarding the expansion of the label for oral semaglutide to include cardiovascular benefits is expected later this year [8]. - Novo Nordisk has also submitted an application for a daily 25 mg oral semaglutide (injection form marketed as Wegovy) for adults with obesity or overweight and cardiovascular disease, with results anticipated by the end of this year [8].