The diabetes drug liraglutide (Victoza) secured an indication from the FDA to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease, Novo Nordisk announced Aug. 25.
Approval came as a result of the LEADER trial, in which liraglutide demonstrated a 13 percent decreased risk in a composite of cardiovascular death, non-fatal heart attack and non-fatal stroke compared with placebo. The drug also showed an absolute risk reduction of 1.9 percent.
The LEADER trial, initiated in September 2010, included 9,340 patients with Type 2 diabetes from 32 countries. Follow-up time ranged from 42 months to five years.
"Today's news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events," Steve Marso, MD, and one of the primary investigators in LEADER said in a statement. "More treatment options like Victozathat address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."
Liraglutide is the second diabetes drug to gain a cardiac indication. Empagliflozin (Jardiance) received FDA approval in December for reducing cardiovascular death risk in patients with Type 2 diabetes and coexisting cardiovascular disease.