FDA Grants Expanded Cardiovascular Indication for Victoza

The FDA last week approved liraglutide (Victoza) to reduce the risk of major cardiovascular (CV) events, heart attack, stroke, and CV death in patients with type 2 diabetes and heart disease, according to a press release. Patients with diabetes are at an increased risk of developing CV disease, highlighting the importance of prevention.

The expanded indication was based on positive results from the LEADER clinical trial. Included in the study were 9340 patients with type 2 diabetes who were randomized to receive liraglutide or placebo in addition to standard of care, including lifestyle changes, glucose-lowering treatments, and CV drugs.

The study showed that liraglutide reduced the risk of CV death, non-fatal heart attack, or non-fatal stroke by 13% compared with placebo. The investigators noted a 1.9% absolute risk reduction, Novo Nordisk reported.

"Physicians have come to rely on Victoza as an effective therapy for lowering A1C, and with this new indication, they now have the option to choose a diabetes medication that also reduces their patient's cardiovascular risk," said Anne Phillips, senior vice president, Clinical, Medical and Regulatory Affairs at Novo Nordisk. "This is good news for patients and health care providers that will also bring much needed attention to the relationship between type 2 diabetes and cardiovascular disease."

Liraglutide is a human glucagon-like peptide-1 analog that was first approved in 2010 to improve blood glucose control, in addition to diet and exercise, in adults with type 2 diabetes.

The most common adverse events include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

Currently, liraglutide is available in 95 countries and treats more than 1 million patients each year, according to Novo Nordisk.

In July, Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA completed a meeting regarding the supplemental new drug application for liraglutide.

Novo Nordisk reported that the committee voted 17-2 in favor of liraglutide 1.8-mg reducing CV risks among patients with type 2 diabetes. All committee members reported that liraglutide did not pose additional cardiovascular risks to patients.

"Today's news is significant for millions of Americans living with type 2 diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events," said Steve Marso, MD, medical director, Cardiovascular Services HCA Midwest Health Heart and Vascular Institute and primary investigator in LEADER. "More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."