Novo Nordisk got the right from the European Medicines Agency’s committee (EMA) to include data from the LEADER trial to Saxenda to the results from the trial showed the long-term effects of Victoza for type 2 diabetes and established cardiovascular disease patients.
On Thursday, Novo Nordisk said that the Committee for Medicinal Products for Human Use (CHMP), under the EMA, has endorsed an update of the EU label for Saxenda.
According to earlier CHMP’s conclusion, and considering that 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) meaningfully 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 company said.
“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 October 25, 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.