Diabetes drug gains FDA indication for CV benefit

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 Victoza that 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.