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

Bagsværd, Denmark, 20 June 2017 - Novo Nordisk today 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 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?"

"Cardiovascular disease is the number one cause of death for people with type 2 diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "With the positive vote today, we are excited to be one step closer towards a cardiovascular indication for Victoza^® to reduce the risk of cardiovascular events in people with type 2 diabetes. We look forward to working with the FDA to include the important results from the LEADER trial in the Victoza^® label."

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.

Conference call

On 21 June 2017 at 8.00 am CEST (2.00 am EDT), Novo Nordisk will host a conference call for investors. Investors will be able to listen in via a link on the investor section of novonordisk.com/investors.

About advisory committees

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing data concerning the safety and effectiveness of marketed or new drug applications.