Novo Nordisk announced that the Food and Drug Administration (FDA)’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of including data from the LEADER trial in the labeling for Victoza (liraglutide) injection.

LEADER was a multi-center, international, randomized, double-blind, placebo-controlled trial that evaluated long-term cardiovascular outcomes in over 9,300 patients with type 2 diabetes at high risk for major cardiovascular events. The study compared Victoza up to 1.8mg to placebo, both in addition to standard of care. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. 

Specifically, the Committee voted 19-0 in favor that the LEADER trial results established no excess cardiovascular risk with the use of Victoza in patients with type 2 diabetes. The Committee also voted 17-2 in favor that the results provided substantial evidence needed to establish that Victoza reduced cardiovascular risk in patients with type 2 diabetes.  

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Victoza, a glucagon-like peptide-1 (GLP-1) analog, is currently indicated to improve glycemic control in type 2 diabetes as adjunct to diet and exercise. It is available as 6mg/mL strength solution for subcutaneous (SC) injection in multi-dose, pre-filled pens. 

The supplemental New Drug Application (sNDA) for Victoza was submitted in October 2016. The FDA is set to take action regarding the sNDA in the third quarter of 2017. 

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