EU approves CV benefit claim for Novo’s Victoza

The European Commission has cleared an update to the drug’s label to reflect both improving blood sugar and cardiovascular (CV) events as key parts of type II diabetes treatment.

Victoza’s (liraglutide) label now includes results from the LEADER trial, which showed that it significantly slashed the risk of CV death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13 percent versus placebo, when added to standard of care.

A significant 22 percent reduction in cardiovascular death was observed in patients taking Novo’s drug versus those in the placebo arm, while a 15 percent drop in all-cause death was also recorded.

"Cardiovascular disease is the number one cause of death for people with type II diabetes and requires treatment strategies that can tackle both blood glucose and cardiovascular risk to help improve outcomes," said Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer.

"The European Commission’s approval of the expanded Victoza label enables physicians to provide their patients with the only GLP-1 proven to prevent cardiovascular events in people with type II diabetes and high cardiovascular risk."

The GLP-1 receptor joins the ranks of Eli Lilly and Boehringer Ingelheim's SGLT-2 inhibitor Jardiance (empagliflozin) with regard to offering CV benefits, offering an important advantage over other diabetes therapies given around half of diabetes-related deaths are caused by heart disease.

Victoza was launched in the EU in 2009 and is available in more than 85 countries.