Posted by Michael Wonder on 27 Aug 2017
Victoza approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of major adverse cardiovascular events
25 August 2017 - The U.S. FDA has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
The FDA's decision is based on the results from the landmark LEADER trial, which demonstrated that Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo, when added to standard of care, with an absolute risk reduction of 1.9%.
The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with Victoza treatment vs placebo, with an absolute risk reduction of 1.3%, and non-significant reductions in non-fatal heart attack and non-fatal stroke.
