Ozempic® approved in the US for CV risk reduction in people with type 2 diabetes and established CVD
(WorldNews Denmark)

Novo Nordisk A/S Inside information Ozempic® approved in the US for CV risk reduction in people with type 2 diabetes and established CVD Rybelsus® label updated with additional information from the PIONEER 6 CV outcomes trial Bagsværd, Denmark, 16 January 2020 - Novo Nordisk today announced that the US Food and Drug Administration (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)....