Novo Nordisk's Victoza approved in EU for cardiovascular events

Pharmaceutical Company Product News

Novo Nordisk has announced that its diabetes drug Victoza has had its European label updated to reflect its cardiovascular benefits.

The European Commission has approved an update to Victoza's label that expands the indication to reflect its capacity to improve blood sugar and cardiovascular events as integral parts of type 2 diabetes treatment.

“Novo Nordisk's Victoza has been approved in Europe as a means of preventing cardiovascular events in people with type 2 diabetes.“

This approval is based on results from the LEADER trial, which demonstrated that Victoza significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction or stroke by 13 percent versus placebo in this patient group, when added to the current standard of care.

LEADER was initiated in September 2010 and involved a total of 9,340 people with type 2 diabetes from 32 countries.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "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."

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