
On Monday, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approved an update to Novo Nordisk A/S‘ (NYSE:NVO) Rybelsus (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial.
SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).