FDA approves expanded CV indication for Victoza
The FDA today approved an expanded indication for the GLP-1 receptor agonist liraglutide to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, myocardial infarction, stroke and cardiovascular disease in adults with type 2 diabetes and established CVD, according to a press release from Novo Nordisk.
The decision is based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide (Victoza, Novo Nordisk) compared with placebo (P = .01).
“Physicians have come to rely on Victoza as an effective therapy for lowering HbA1c, and with this new indication, they now have the option to choose a diabetes medication that also reductions their patients’ cardiovascular risk,” Anne Phillips, senior vice president of clinical, medical and regulatory affairs for Novo Nordisk, said in the release. “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.”
“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,” Steve Marso, MD, medical director of cardiovascular services at HCA Midwest Health Heart and Vascular Institute, said in the release. “More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are effectual to confront this pervasive issue.”