Novo Nordisk files for EU and USA label for Victoza to include LEADER data

Danish diabetes care giant Novo Nordisk (NOV: N) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration and a Type II Variation application to the European Medicines Agency for including data from the LEADER cardiovascular outcomes trial in the product information of its blockbuster type 2 diabetes treatment Victoza (liraglutide).

In the LEADER trial, Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction (heart attack) and non-fatal stroke by 13% versus placebo, when added to standard of care. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza treatment versus placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke.

Victoza’s cardiovascular risk-reduction data, released at the American Diabetes Association (ADA) conference in New Orleans back in June, follows Eli Lilly and Boehringer Ingelheim’s EMPA-REG outcomes trial, in which their SGLT-2 drug Jardiance (empagliflozin) reduced the MACE risk by 14% and cut cardiovascular death risk by 38%.