Novo Nordisk Diabetes Drug Victoza Approved In US To Reduce Cardiovascular Risk

(RTTNews) - Novo Nordisk A/S (NVO) announced that U.S. FDA has approved a new indication for Victoza (liraglutide) to reduce risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease.

In the US, Victoza® was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.

The FDA's decision is based on the results from landmark LEADER trial, which demonstrated that Victoza® statistically significantly reduced risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo, when added to standard of care, with absolute risk reduction of 1.9%.

The company noted that overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza® treatment vs placebo, with an absolute risk reduction of 1.3%, and non-significant reductions in non-fatal heart attack and non-fatal stroke.