Copenhagen-based healthcare giant Novo Nordisk (NYSE: NVO) has declared the primary outcomes of the SOUL cardiovascular outcomes trial, showcasing that its oral glucagon-like peptide-1 (GLP-1) analogue, semaglutide, successfully reduced major adverse cardiovascular events (MACE) by 14%.
The SOUL trial, a global, multi-center, randomized, double-blinded, and parallel-controlled study, enrolled 9,650 individuals with type 2 diabetes and a history of cardiovascular disease (CVD) and/or chronic kidney disease (CKD). The trial’s primary endpoint was the first occurrence of MACE, which includes cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Commenced in 2019, the study reaffirmed the safety and tolerability profile of oral semaglutide, aligning with previous research outcomes. The company anticipates filing for indication extension in the US and European Union around the year’s end.
First approved in the US in 2017, semaglutide is now commercially available in 52 countries/regions worldwide. The injectable form of the drug received marketing approval in China for type 2 diabetes in 2021, with the oral dosage form following suit in January of this year. Additionally, semaglutide gained marketing clearance for obesity treatment in China in June this year.- Flcube.com
