FDA Grants Liraglutide Cardiovascular Events Indication

Miriam E. Tucker

Disclosures

August 25, 2017

The US Food and Drug Administration (FDA) has approved a new indication for liraglutide (Victoza, Novo Nordisk), for reducing the risk for myocardial infarction, stroke, and cardiovascular death in adults with type 2 diabetes who have established cardiovascular disease.

Today's approval marks the second time a drug initially approved for glucose lowering in type 2 diabetes has gained an additional indication for cardiovascular benefit based on results from FDA-mandated cardiovascular outcomes trials. The first, empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals Inc), received an indication for improving survival in adults with type 2 diabetes and cardiovascular disease in December 2016.

The new approval for liraglutide is broader, encompassing prevention of cardiovascular events as well as death. The FDA's decision was based on results from the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation) trial, in which liraglutide reduced the risk for the composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke by 13% compared with placebo (P = .01), with an absolute risk reduction of 1.9%.  

The announcement is not unexpected, as an FDA advisory panel endorsed the new indication by a 17-2 vote in June 2017 and the FDA usually follows the advice of its panels. 

In 2014, the FDA also approved liraglutide for weight loss, at a higher dose (Saxenda).  

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