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Novo Nordisk (NVO) Says CHMP Endorses EU Label Update of Saxenda

June 22, 2017 2:26 PM EDT

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Novo Nordisk (NYSE: NVO) 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 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.



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