Novo Nordisk says FDA approves new indication for Ozempic
- Novo Nordisk (NYSE:NVO) says the Food and Drug Administration approved a new indication for Ozempic (semaglutide) to "reduce the risk of major adverse cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes and known heart disease."
- Novo says the FDA decision was based on results from the SUSTAIN 6 trial, which examined "the cardiovascular safety of adding Ozempic or placebo to standard of care in adults with type 2 diabetes and established cardiovascular disease."
- Ozempic already is indicated for use to improve blood sugar in adults with type 2 diabetes mellitus and to reduce the risk of major cardiovascular events in adults with type 2 diabetes mellitus with known heart disease.