Positive FDA panel vote on new Victoza indication

The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) 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), Danish diabetes care giant Novo Nordisk’s (NOV: N) already blockbuster drug.

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?"