FDA Approves Victoza (liraglutide) to Reduce Cardiovascular Risk

FDA Approves Victoza (liraglutide) to Reduce Cardiovascular Risk 

What:

On August 25, 2017, FDA approved a new indication for liraglutide (Victoza), allowing its use to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes (T2D) and established cardiovascular disease (CVD).

Why this matters:

CVD is a leading cause of morbidity and mortality in T2D.

How approval occurred:

FDA's decision was based on data from the multicenter, randomized, double-blinded LEADER  trial involving 9,340 people with T2D and CVD, in which liraglutide reduced three-component endpoint by 13% versus placebo at 3.5-5 years (p=.01), absolute risk reduction 1.9%.

Key Facts:

•Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog approved in 2010 as adjunct to diet and exercise to improve glycemic control in adults with T2D.

•In 2014, a higher dose of liraglutide (Saxenda) was approved for weight loss.

•Liraglutide’s most common side effects include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

•In 2016, another glucose-lowering drug, Jardiance (empagliflozin) was approved for reduction of CV death.

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration