FDA posts briefing materials prior to Advisory Committee meeting for Victoza® label update
Bagsværd, Denmark, 16 June 2017 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss the supplemental New Drug Application (sNDA) for approval of Victoza® (liraglutide) injection to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk, given as an adjunct to standard treatment of cardiovascular risk factors.
The meeting takes place on 20 June 2017. The briefing documents from Novo Nordisk and the FDA form the basis for the Advisory Committee's discussion, and provide an overview of the clinical data from the cardiovascular outcomes trial LEADER.
The briefing materials can be accessed on the FDA webpage:
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.
About the LEADER trial
LEADER was a multicentre, international, randomised, double-blind, placebo-controlled trial investigating the long-term (3.5-5 years) effects of Victoza® (liraglutide up to 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.
LEADER was initiated in September 2010 and randomised 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Victoza® (liraglutide) injection is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1.
Victoza® was approved in the EU in 2009 and is commercially available in more than 90 countries, treating more than 1 million people with type 2 diabetes globally. In Europe, Victoza® is indicated for the treatment of adults with type 2 diabetes to achieve glycaemic control as monotherapy, when metformin is considered inappropriate, and in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.In the US, Victoza® was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,000 people in 77 countries and markets its products in more than 165 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube
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Company announcement No 45/2017