FDA approves new indication for Victoza (liraglutide) to cut risk of CV events in type 2 diabetes.-Novo Nordisk.

The FDA has approved a new indication for Victoza (liraglutide), from Novo Nordisk, to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. The FDA's decision is based on the results from the landmark LEADER trial, which demonstrated that Victoza significantly reduced the risk of a three component endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo (p=0.01) with an absolute risk reduction (ARR) of 1.9%.