Novo Nordisk $NVO announced that it has submitted New Drug Application (sNDA) in the U.S. and a Type II Variation application in Europe seeking approval to add the cardiovascular (CV) outcomes data generated from the LEADER study in type 2 diabetics to the package insert of diabetes med Victoza (liraglutide). Results from LEADER showed treatment with Victoza reduced the risk of CV death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13% compared to placebo when added to standard of care. The overall risk reduction was derived from a statistically significant reduction of 22% in CV death versus placebo and non-statistically significant reductions in non-fatal heart attack and stroke. The large scale study (9,000+ participants) was initiated in mid-2010.