Added indication approved for Victoza by FDA

The US Food and Drug Administration has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease, Danish diabetes care giant Novo Nordisk (NOV: N), the drug’s maker announced on Friday, after the Danish stock market had closed..

The FDA's decision is based on the results from the landmark LEADER trial, which demonstrated that Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% versus placebo, when added to standard of care, with an absolute risk reduction of 1.9%.The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza treatment versus placebo, with an absolute risk reduction of 1.3%, and non-significant reductions in non-fatal heart attack and non-fatal stroke.

"This approval marks an important milestone for millions of Americans living with type 2 diabetes, as cardiovascular disease is the number one cause of death in this patient population," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "Victoza now offers people with type 2 diabetes and established cardiovascular disease an effective treatment option to both lower their blood glucose and reduce their cardiovascular risk," he added.

Victoza is the second time a drug initially approved for glucose lowering in type 2 diabetes that has gained an additional indication for cardiovascular benefit based on results from FDA-mandated cardiovascular outcomes trials.