Novo Nordisk : FDA Posts Briefing Materials Prior To FDA Panel On Victoza

(RTTNews) - Novo Nordisk said that the US Food and Drug Administration has published the briefing documents ahead of the Advisory Committee meeting to discuss the supplemental New Drug Application or 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.