FDA Expands Indication for Victoza

The indication for Victoza was recently expanded to include the reduction of major adverse cardiovascular events, heart attack, stroke, and cardiovascular-associated death among patients with type 2 diabetes and established cardiovascular disease by the US Food and Drug Administration.

Victoza was approved in 2010 as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
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The approval to expand the drug’s indication was based on results from the LEADER trial, which demonstrated that Victoza significantly reduced the risk of cardiovascular death, non-fatal heart attack, and non-fatal stroke by 13%, with an absolute risk reduction of 1.9%, compared with placebo.

Common adverse effects of Vitroza include nausea, diarrhea, vomiting, decrease appetite, indigestion, and constipation.

—Melissa Weiss

Reference:

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 [press release]. Plainsboro, NJ: Novo Nordisk, August 25, 2017. 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. Accessed August 28, 2017.