FDA Grants Cardiovascular Indication for Liraglutide

August 25, 2017. The US Food and Drug Administration has granted a new indication for the diabetes drug liraglutide: to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease. This decision was based on data from the landmark LEADER trial, which found that adding liraglutide to standard of care reduced the risk of a composite CV endpoint by 13% vs placebo, representing a 1.9% absolute risk reduction (ARR). The LEADER trial also found a 22% reduction in CV death with liraglutide vs placebo (ARR 1.3%). Read the full news release here.