The FDA approved a new indication for Novo Nordisk‘s (NYSE:NVO) Victoza liraglutide injection, clearing it as the only Type II diabetes medication indicated to reduce the risk of cardiovascular diseases, like heart attack and stroke.
The regulatory watchdog’s decision is based on results from Nordisk’s 9,300-patient Leader trial, which showed that Victoza significantly reduced the risk of cardiovascular death, non-fatal heart attack and non-fatal stroke.
Heart disease is a leading cause of death in diabetes patients, according to the Plainsboro, N.J.-based company.
“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 SVP of clinical, medical & regulatory affairs, said in prepared remarks. “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 II diabetes because, even when controlled, diabetes puts patients at a greater risk for cardiovascular events,” Dr. Steve Marso, one of the primary investigators in Leader, added. “More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue.”
NVO shares were trading at $46.13 apiece in mid-afternoon activity today, up 1.1%.