EU approves label addition for Victoza (liraglutide) in type II diabetes -Novo Nordisk
The EU has approved an update to the label of Victoza (liraglutide), from Novo Nordisk, to recognise that improvements in both blood sugar and cardiovascular events represent key aspects of treatment for type II diabetes. The drug's label will now include data from the LEADER trial, showing a significant reduction in the risk of CV death, non-fatal myocardial infarction or non-fatal stroke by 13% percent versus placebo, in addition to standard care.
Comment: In addition, Novo Nordisk recently announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has completed its meeting regarding the supplemental New Drug Application (sNDA) for inclusion of the data from the cardiovascular outcomes trial LEADER in the label for Victoza (liraglutide).
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