Novo blockbuster wins MACE label claim

Jan. 17, 2020

Novo Nordisk announced that the U.S. FDA has approved a label expansion based on a supplemental New Drug Application (sNDA) for Ozempic, 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.

The label boost will help Novo Nordisk as it continues to battle Eli Lilly's leading GLP-1 drug, Trulicity for market share.

The approval is based on the SUSTAIN 6 cardiovascular outcomes trial, which demonstrated that Ozempic 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.

Ozempic was first approved by the U.S. FDA in 2017 as an injectable prescription medicine for adults with type 2 diabetes.

Read the press release