Novo Nordisk A/S said the U.S. Food and Drug Administration approved a label expansion for the company's blockbuster diabetes drug Ozempic.
The U.S. regulator granted the label expansion to the injectable drug for reducing the risk of major adverse cardiovascular events — including cardiovascular death, nonfatal heart attack or nonfatal stroke — in adults with type 2 diabetes and established cardiovascular disease.
The approval was supported by results of a phase 3 trial called Sustain 6, in which Ozempic reduced the risk of major adverse heart events by 21% compared to placebo, according to a Jan. 16 news release.
The U.S. FDA first approved Ozempic in 2017 to improve glycemic control in adults with type 2 diabetes. Ozempic is also approved in the EU and Japan, among other territories.