Europe adds CV risk claims to label for Novo's Victoza

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) said the European Commission approved a label expansion for Type II diabetes drug Victoza liraglutide (NN2211) to add a claim of reduced cardiovascular risk. The company said Victoza is the only glucagon-like peptide-1 (GLP-1) analog with a European label that includes prevention of CV events.

The drug’s label will now include data from the 9,340-patient Phase III LEADER CV outcomes trial (CVOT) showing that compared to placebo, Victoza significantly reduced CV risk by 13% as measured by time to first occurrence of major adverse CV events (MACE) (see BioCentury, June 20, 2016)...