Officials with Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has completed its meeting regarding the supplemental New Drug Application (sNDA) for liraglutide (Victoza) and noted that it is not associated with excess cardiovascular risk in patients with type 2 diabetes.
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 and compared liraglutide to placebo, in addition to standard of care. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.
The committee voted unanimously on the cardiovascular risk issue, and voted 17-2 in favor of Victoza on the question: "Does the LEADER trial provide the substantial evidence needed to establish that
liraglutide 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes?"
The sNDA was submitted to the FDA in October 2016 and regulatory feedback in the US is expected in Q3 2017. In Europe, a type 2 variation application was submitted to the European Medicines Agency (EMA) in October 2016.
Novo Nordisk receives positive 17-2 vote from FDA Advisory Committee that Victoza® provides substantial evidence of cardiovascular risk reduction in patients with type 2 diabetes [news release]. Plainsboro, NJ. Novo Nordisk website Accessed June 20, 2017 at: http://press.novonordisk-us.com/2017-06-20-Novo-Nordisk-receives-positive-17-2-vote-from-FDA-Advisory-Committee-that-Victoza-R-provides-substantial-evidence-of-cardiovascular-risk-reduction-in-patients-with-type-2-diabetes