NVO : FDA Oks Ozempic For CV Risk Reduction In Type 2 Diabetes & Established CVD

(RTTNews) - Novo Nordisk said that the U.S. Food and Drug Administration has approved a label expansion based on a supplemental New Drug Application or sNDA for Ozempic for the indication of reducing the risk of major adverse cardiovascular events or MACE including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease or CVD.

The approval was 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.

The FDA also updated the Rybelsus label to include additional information from the PIONEER 6 CVOT demonstrating CV safety.