Endocrinologic and Metabolic Drugs Advisory Committee of FDA votes in favour of inclusion of CV outcomes data from LEADER trial in Victoza (liraglutide) label.- Novo Nordisk.

Novo Nordisk 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).

The discussions at the Advisory Committee meeting were based on data from the LEADER trial, which involved more than 9,300 people with type 2 diabetes at high risk of major cardiovascular events. The Advisory Committee voted 19-0 in favour of Victoza on the question: "Do the results of LEADER establish that use of Victoza in patients with type 2 diabetes is not associated with excess cardiovascular risk?" The Advisory Committee voted 17-2 in favour of Victoza on the question: "Does the LEADER trial provide the substantial evidence needed to establish that Victoza (liraglutide 1.8 mg) reduces cardiovascular risk in patients with type 2 diabetes?"

The supplemental New Drug Application for Victoza was submitted to the FDA in October 2016 and regulatory feedback in the US is expected in Q3 2017. In Europe, a Type II Variation application was submitted to the European Medicines Agency (EMA) in October 2016.