FDA panel's vote favors Victoza's CV risk claims

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 17-2 that results of a cardiovascular outcomes trial (CVOT) provided "substantial evidence" that treatment with Victoza liraglutide (NN2211) from Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) reduces cardiovascular (CV) risk in Type II diabetics with established CV disease. The committee also voted unanimously that the trial, the Phase III LEADER trial, showed Victoza is not associated with excess CV risk.

Novo markets the long-acting glucagon-like peptide-1 (GLP-1) analog as adjunct treatment to improve glycemic control in Type II diabetics, and is seeking to add a claim of reduced CV risk to the drug's label...