US regulatory advisors are backing the claim that Novo Nordisks’ Victoza reduces cardiovascular risk in patients with diabetes.
The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 17-2 that data from the LEADER trial should be included the drug’s label.
The trial investigated the long-term (3.5 – 5 years) effects of Victoza (liraglutide up to 1.8mg) compared to placebo, both in addition to standard of care, in people with type II diabetes at high risk of major cardiovascular events.
Findings, presented at the American Diabetes Association's 76th Scientific Sessions, show that the drug slashed the composite primary endpoint of cardiovascular (CV) death, non-fatal heart attack or non-fatal stroke by 13 percent versus vs placebo when added to standard of care.
A significant 22 percent reduction in cardiovascular death was observed in patients taking Victoza versus those in the placebo arm, while a 15 percent drop in all-cause death was also recorded.
"Cardiovascular disease is the number one cause of death for people with type II diabetes, and [the Committee’s] discussion is an important reminder that there is an unmet need to provide benefits beyond HbA1c control in this population," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk.
"The positive vote from EMDAC puts us one step closer to expanding our offering to reduce the risk of cardiovascular events in people with type II diabetes."
The GLP-1 receptor joins the ranks of Eli Lilly and Boehringer Ingelheim's SGLT-2 inhibitor Jardiance with regard to offering CV benefits, offering an important advantage over other diabetes therapies given around half of diabetes-related deaths are caused by heart disease.
Victoza was launched in the EU in 2009 and is commercially available in more than 85 countries, treating more than 1 million people with type II diabetes globally.