Novo Nordisk A/S: CHMP adopts positive opinion for EU label update of Victoza® based on the LEADER trial. 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.
Bagsværd, Denmark, 23 June 2017 - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), has issued a positive opinion on update of the EU label for Victoza(®). The update is based on the results from the LEADER trial which investigated the long-term effects of Victoza(®) (liraglutide up to 1.8 mg) in people with type 2 diabetes, at high risk of major cardiovascular (CV) events.
In the LEADER trial, Victoza(®) (liraglutide up to 1.8 mg) statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) and 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.
The CHMP has recommended an update of the indication for Victoza(®) to reflect both glycaemic control and cardiovascular events as integral parts of type 2 diabetes treatment.
"Cardiovascular disease is the leading cause of death for people with type 2 diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "There remains an unmet medical need to further reduce cardiovascular risk in people with type 2 diabetes and we are very pleased that the CHMP has recommended the Victoza(®) label update based on the LEADER trial."
The CHMP positive opinion for Victoza(®) is now referred to the European Commission, which grants approval in the EU, for final action on the proposed indication. Novo Nordisk expects to receive the European Commission decision for the Victoza(®) label update in the third quarter of 2017.
About Victoza(®) Victoza(®) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Victoza(®) was approved in the EU in 2009 and is commercially available in more than 95 countries, treating more than 1 million people with type 2 diabetes globally. In Europe, Victoza(®) is indicated for the treatment of adults with type 2 diabetes to achieve glycaemic control as monotherapy, when metformin is considered inappropriate, and in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. In the US, Victoza(®) was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.
About the LEADER trial LEADER was a multicentre, international, randomised, double-blind, placebo- controlled trial investigating the long-term (3.5-5 years) effects of Victoza(®) (liraglutide up to 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose- lowering treatments and cardiovascular medications.
LEADER was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
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Company announcement No 49 / 2017
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