The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide) as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in overweight and obese adults with established cardiovascular disease (CVD) and without established Type 1 or Type 2 diabetes. The indication extension was registered by the TGA on 19 December 2024.
Novo Nordisk obtained US approval for the same indication of Wegovy® in March 2024. In July 2024, the CHMP adopted a positive opinion for an update to the label for Wegovy® in Europe to reflect a risk reduction of MACE in adults with established CVD and either overweight or obesity without diabetes.