A top-selling diabetes drug has gained a cardiovascular (CV) indication from FDA.
FDA has expanded the indication for liraglutide (Victoza, Novo Nordisk) to include reducing the risk of major cardiovascular events, heart attack, stroke and CV death.
Sales of the blockbuster drug soared 25% to $843 million in the first quarter of 2017, according to Novo Nordisk.
“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 Service, HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in the LEADER trial. “More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue.”
Novo Nordisk’s LEADER trial demonstrated that Victoza reduced the risk of cardiovascular death by 22% and resulted in all-cause death by 15%. Victoza demonstrated an absolute risk reduction (ARR) of 1.9% during the trial.
“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 of Clinical, Medical and Regulatory Affairs for Novo Nordisk.