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, heart attack, stroke and CV death, 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 significantly reduced the risk of a three-component endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo (p=0.01) with an absolute risk reduction (ARR) of 1.9%.

"Physicians have come to rely on Victoza as an effective therapy for lowering A1C, and with this new indication, they now have the option to choose a diabetes medication that also reduces their patient's cardiovascular risk," said Anne Phillips, Senior Vice President, Clinical, Medical and Regulatory Affairs for Novo Nordisk. "This is good news for patients and health care providers that will also bring much needed attention to the relationship between type 2 diabetes and cardiovascular disease."

Cardiovascular disease is the leading cause of morbidity and mortality in patients with diabetes. Studies have shown that adults with type 2 diabetes are up to four times more likely to develop cardiovascular disease. Victoza demonstrated a life-saving benefit that included a 22% reduction in cardiovascular death and a 15% reduction in all-cause death (ARR 1.3%, 1.4% respectively).