Novo Nordisk A/S: CHMP endorses EU label update of Saxenda® based on the LEADER trial

Bagsværd, Denmark, 22 June 2017 - Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP), under theEuropean Medicines Agency (EMA), has endorsed an update of the EU label for Saxenda®. This update is based on the results from the LEADER trial which investigated the long-term effects of Victoza® in people with type 2 diabetes and established cardiovascular disease.

The CHMP has previously concluded that, although the Saxenda® dosing of liraglutide 3.0 mg was not investigated in the LEADER trial, the results would also be supportive for the assessment of Saxenda® for any potential cardiovascular risk. The Saxenda® label has been updated with immediate effect to reflect the primary outcome of the LEADER trial. 

In the LEADER trial, Victoza® (liraglutide 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.

"We are very pleased that data from the LEADER trial has been included in the Saxenda® label in Europe," said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "The LEADER trial showed that liraglutide is associated with significant cardiovascular risk reduction in people with type 2 diabetes. This is an important development for people with obesity in Europe living with weight-related comorbidities such as cardiovascular disease."

On 25 October 2016, Novo Nordisk submitted an application to the EMA for including data from the LEADER cardiovascular outcomes trial in the product information of Victoza®. Novo Nordisk expects feedback from the EMA on the Victoza® application shortly.

About Saxenda®   

Saxenda® (liraglutide 3 mg) is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, Saxenda® regulates appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, Saxenda® stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner. Saxenda® was evaluated in the SCALE (Satiety and Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial programme.

In the EU, Saxenda® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of >30 kg/m2 (obese), or >27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes), hypertension, dyslipidaemia or obstructive sleep apnoea.

About Victoza®
Victoza® (liraglutide 1.2 mg and 1.8 mg) 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 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes with established cardiovascular disease. 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.

Further information

Katrine Sperling +45 3079 6718
Ken Inchausti (US) +1 609 786 8316
Peter Hugreffe Ankersen +45 3075 9085
Hanna Ögren +45 3079 8519
Anders Mikkelsen +45 3079 4461
Kasper Veje (USA) +1 609 235 8567

Company announcement No 48 / 2017