Novo Nordisk's Victoza approved for new indication by FDA

Novo Nordisk’s study showed Victoza reduced the risk of cardiovascular death.
Novo Nordisk’s study showed Victoza reduced the risk of cardiovascular death. | Contributed image

Novo Nordisk recently announced that the U.S. Food and Drug Administration approved a new indication for Victoza, which should help reduce the risk of major adverse cardiovascular events, heart attack and stroke in adults with Type 2 diabetes and established cardiovascular disease.

"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," Anne Phillips, senior vice president of clinical, medical and regulatory affairs for Novo Nordisk, said in a statement. "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."

To make the decision, the FDA analyzed results from Novo Nordisk’s Leader trial. The study showed that Victoza reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13 percent when compared to a placebo.

"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," Dr. Steve Marso, medical director of cardiovascular services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in the study, said. "More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."

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Novo Nordisk Inc. 800 Scudders Mill Rd Plainsboro, NJ 08536