The U.S. Food and Drug Administration (FDA) 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.
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, nonfatal heart attack or non-fatal stroke by 13% vs 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 vs 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.”