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Novo’s Victoza has been approved in the EU


The European Commission has approved an update to the Victoza (liraglutide) EU label that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events as integral parts of type 2 diabetes treatment.

Victoza is the only GLP-1 that is proven to prevent CV events in people with type 2 diabetes and high CV risk.

The updated label includes results from the LEADER trial, which demonstrated that Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% versus placebo, when added to standard of care. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza treatment versus placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke.

“Cardiovascular disease is the number one cause of death for people with type 2 diabetes and requires treatment strategies that can tackle both blood glucose and cardiovascular risk to help improve outcomes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “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 2 diabetes and high cardiovascular risk.”