FDA panel to assess Victoza's CV benefit, discuss risks

Briefing documents released ahead of a meeting to discuss Victoza liraglutide from Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) said an FDA advisory committee will vote on whether data from a cardiovascular outcomes trial show that Victoza is not associated with excess CV risk, and whether they provide "substantial evidence" the drug reduces CV risk among Type II diabetics with high CV risk.

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) is to meet June 20 to discuss an sNDA that would expand Victoza's label to include adjunct treatment to standard of care (SOC) to reduce the risk of major adverse CV events (MACE) of CV death, non-fatal myocardial infarction (MI) or non-fatal stroke. The long-acting analog of glucagon-like peptide-1 (GLP-1) is already approved as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes...