FDA adds CV risk claims to Victoza label

Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) said FDA approved a label expansion for Type II diabetes drug Victoza liraglutide to add a claim that it reduces the risk of three major adverse cardiovascular events -- CV death, non-fatal myocardial infarction (MI) and non-fatal stroke -- in adults with established CV disease.

In June, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 17-2 that the 9,340-patient Phase III LEADER CV outcomes trial (CVOT) provided "substantial evidence" that Victoza reduces CV risk in the population. The committee also voted unanimously that the trial showed Victoza is not associated with excess CV risk (see BioCentury Extra, June 28). ...