FDA approves label extension for Ozempic for reduction of risk of major adverse cardiovascular events in type 2 diabetes.- Novo Nordisk

Novo Nordisk has announced that the FDA has approved a label expansion based on a supplemental New Drug Application (sNDA) for Ozempic (once-weekly semaglutide) 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.