Liraglutide Gains New Indication for Reducing CV Event Risk

Novo Nordisk announced that its diabetes drug liraglutide (Victoza) has been approved by the FDA for a new indication: it can reduce the risk of 3 major cardiovascular (CV) events in patients with type 2 diabetes (T2D) and existing CV disease.

Approval of the new indication was based on results from the LEADER trial presented in June 2016 at the 76th Scientific Sessions of the American Diabetes Association. That trial showed that liraglutide cut the risk of CV death by 22% and reduced major CV events by 13% versus placebo, as well as lowering the risk of death from any cause by 15%.

Those findings were unexpected, considering the main objective of the Liraglutide Effect and Action in Diabetes of Cardiovascular Outcomes Results (LEADER) trial was simply to demonstrate the drug’s CV safety. However, the findings set the groundwork for liraglutide’s indications to be expanded beyond treating T2D to the new indication of lowering the risk of major CV events.

Liraglutide is now the only GLP-1 therapy for T2D approved in the US to reduce the risk of major CV events, which include CV death, nonfatal heart attack, and nonfatal stroke. Empagliflozin, a SGLT2 inhibitor used to treat T2D, was approved for the indication of preventing CV death in December 2016.

“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, in the announcement. “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.”

Novo’s announcement noted the fact that adults with T2D are 4 times more likely to develop CV disease, which is the leading cause of death in patients with diabetes.

“More treatment options like Victoza that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue,” said Steve Marso, MD, one of LEADER’s primary investigators, in the press statement.

In an interview with The American Journal of Managed Care^®, Todd Hobbs, MD, vice president and chief medical officer of Novo Nordisk North America, discussed the importance of liraglutide being the first GLP-1 to receive a CV indication from FDA.

“As the number one prescribed GLP-1, physicians have come to rely on Victoza as an effective therapy for lowering A1C in patients with type 2 diabetes, and with this new indication, they now have the option to choose a diabetes medication that also reduces their patient’s CV risk,” he said. “Patients with type 2 diabetes are at increased risk for CV events, so treatment options like Victoza that help to address critical aspects of diabetes care beyond glucose lowering are essential for diabetes management.”

AJMC^® asked whether this new indication means anything for the position of Novo Nordisk’s combination therapy, Xultophy, which combines insulin degludec (Tresiba) and liraglutide. Hobbs said, “It is important to remember that the combination itself has not been studied in patients at high risk for CV disease as was done in the LEADER trial, so we can’t directly draw these conclusions.”

Why is this new indication important for payers? “Type 2 diabetes management requires solutions that address critical aspects of diabetes care beyond A1C reduction, as adults with diabetes are up to four times more likely to develop cardiovascular disease,” Hobbs said. “In fact, CV disease is the leading cause of morbidity and mortality in patients with diabetes.

“With this approval, healthcare providers will now have a treatment option that has been proven to be efficacious in lowering A1C, weight, and importantly reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes.”