Posted by Michael Wonder on 17 Jan 2020
Ozempic approved in the US for CV risk reduction in people with type 2 diabetes and established CVD
16 January 2020 - Rybelsus label updated with additional information from the PIONEER 6 CV outcomes trial.
Novo Nordisk today announced that the US FDA has approved a label expansion based on a supplemental new drug application for Ozempic (once-weekly semaglutide) for the indication of reducing the risk of major adverse cardiovascular events including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease.
The approval is based on the SUSTAIN 6 cardiovascular outcomes trial, 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.
