FDA Advisors Support Adding New Cardiovascular Data to Liraglutide Label

Date: 
June, 2017

June 20, 2017. The U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has reviewed a supplemental new drug application for liraglutide. Specifically, the manufacturer of liraglutide requested to update liraglutide’s labeling based on data from LEADER, a pivotal cardiovascular outcomes trial that evaluated >9,300 patients with type 2 diabetes at high risk of major cardiovascular events. The FDA committee voted unanimously (19-0) for liraglutide on the question: “Do the results of LEADER establish that use of liraglutide in patients with type 2 diabetes is not associated with excess cardiovascular risk?” The committee also voted 17-2 in favor of liraglutide on the question: “Does the LEADER trial provide the substantial evidence needed to establish that [liraglutide] 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes?” Click here for full article