Novo Nordisk announced that the US Food and Drug Administration has approved a label expansion based on a supplemental New Drug Application (sNDA) for Ozempic® for the indication of reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease (CVD). The approval is based on the SUSTAIN 6 cardiovascular outcomes trial (CVOT), which demonstrated that Ozempic® statistically significantly reduced the risk of CV death, non- fatal heart attack or non-fatal stroke by 26% versus placebo, when added to standard of care in people with type 2 diabetes with increased CV risk. The FDA also updated the Rybelsus® label to include additional information from the PIONEER 6 CVOT demonstrating CV safety. Rybelsus® demonstrated CV safety by meeting the primary endpoint of non-inferiority for the composite MACE endpoint. The proportion of patients who experienced at least one MACE was 3.8% with Rybelsus® and 4.8% with placebo.