Skip to main content

Victoza (liraglutide) is Approved to Reduce the Risk of Three Major Adverse Cardiovascular Events in Type 2 Diabetes Patients

PLAINSBORO, N.J., Aug. 25, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.1

The FDA's decision is based on the results from the landmark LEADER trial, which demonstrated that Victoza significantly reduced the risk of a three component endpoint consisting of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% vs placebo (p=0.01) with an absolute risk reduction (ARR) of 1.9%.1

"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, Clinical, Medical and Regulatory Affairs for Novo Nordisk. "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."

Cardiovascular disease is the leading cause of morbidity and mortality in patients with diabetes.2 Studies have shown that adults with type 2 diabetes are up to four times more likely to develop cardiovascular disease.3 Victoza demonstrated a life-saving benefit that included a 22% reduction in cardiovascular death and a 15% reduction in all-cause death (ARR 1.3%, 1.4% respectively).

"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 Services HCA Midwest Health Heart and Vascular Institute and one of the primary investigators in LEADER. "More treatment options like Victoza® that address critical aspects of diabetes care beyond glucose lowering are essential to confront this pervasive issue."

About Victoza

Victoza (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is commercially available in 95 countries, treating more than 1 million people with type 2 diabetes globally.4

Eligible patients with commercial insurance can use the Victoza® Instant Savings Card to reduce co-pays to as low as $25 a month for up to 48 months. Eligibility and other restrictions apply. For complete terms and conditions and any questions regarding eligibility, visit https://www.victoza.com/content/victoza/en/consider-using-victoza-/save-on-your-prescription.html or call 1-855-292-5966.

About the LEADER trial

LEADER was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of Victoza (liraglutide) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major adverse cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.5

The landmark LEADER trial was initiated in September 2010 and randomized 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprised of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.5

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

References

  1. Victoza [package insert]. Plainsboro, NJ: Novo Nordisk Inc; August 2017.
  2. Low Wang CC, Hess CN, Hiatt WR, Goldfine AB. Clinical Update: cardiovascular disease in diabetes mellitus. Atherosclerotic cardiovascular disease and heart failure in type 2 diabetes mellitus–mechanisms, management, and clinical considerations. Circulation. 2016; 133:2459-2502.
  3. World Heart Federation. Cardiovascular Disease Risk Factors. Available at: www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/. Accessed August 25, 2017.
  4. Internal Calculations based on IMS Midas Quantum data. December 2016.
  5. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2016; 375:311-322.

SOURCE Novo Nordisk

Posted: August 2017

Related articles

Victoza (liraglutide) FDA Approval History

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.