FDA: Liraglutide Approved for MACE in T2D With Established CVD

heart attack cropped
heart attack cropped
Approval for the new indication follows a review of the results of the LEADER trial.

Liraglutide (Victoza®; Novo Nordisk) has received approval by the US Food and Drug Administration (FDA) for a new indication to reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes (T2D) and established cardiovascular disease. This approval marks the first time a drug has  been approved for this indication.

The approval follows reporting of results from the LEADER trial (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results; ClinicalTrials.gov Identifier: NCT01179048) at a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in June 2017. Trial data showed that liraglutide reduced the risk of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke by 13% compared with placebo (absolute risk reduction: 1.9%; P =.01).

LEADER was a landmark international trial that included 9340 people with T2D and at high risk for major cardiovascular events.

“[E]ven when controlled, diabetes puts patients at a greater risk for cardiovascular events,” said Steve Marso, MD, medical director of cardiovascular services at HCA Midwest Health Heart and Vascular Institute, Kansas City, Missouri, and primary LEADER study investigator, in a press release. “More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue.”

Liraglutide, a glucagon-like peptide-1 (GLP-1) analog, is contraindicated in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) or patients with a family history of medullary thyroid cancer (MTC). Serious side effects include possible thyroid tumors.

Liraglutide is available as 1.2-mg or 1.8-mg injections.

Related Articles


Victoza® (liraglutide) is approved in the US as the only type 2 diabetes treatment indicated to reduce the risk of three major adverse cardiovascular events [news release]. Plainsboro, NJ: Novo Nordisk. http://press.novonordisk-us.com/2017-08-25-Victoza-R-liraglutide-is-approved-in-the-US-as-the-only-type-2-diabetes-treatment-indicated-to-reduce-the-risk-of-three-major-adverse-cardiovascular-events. Published August 25, 2017. Accessed August 30, 2017.