FDA approves Victoza® for the treatment of type 2 diabetes in children and adolescents aged 10-17 years

PLAINSBORO, NJ, USA I June 17, 2019 I Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza® (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes. As the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, Victoza® provides this population with a new treatment option beyond metformin and insulin for the first time in 19 years. Victoza® was first approved in the U.S. in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The update is based on results from the global ELLIPSE trial, the first phase 3 trial completed in over a decade in children and adolescents with type 2 diabetes. In this study, patients aged 10 to 17 were randomized to receive liraglutide up to 1.8 mg/day or placebo, in combination with metformin with or without basal insulin over a 26-week double-blinded period followed by a 26-week open-label extension period.1

"We are delighted with the label expansion for Victoza®, which now includes an indication for use in children and adolescents with type 2 diabetes in the U.S. - this is a landmark approval as the first-ever GLP-1 receptor agonist approved for this population," commented Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The prevalence of type 2 diabetes in the U.S. is ever increasing and we are seeing a higher number of diagnoses in children and adolescents, for whom there are limited treatment choices. Victoza® will provide a new option for clinicians treating this challenging disease, helping to address the growing need for this population."

According to the World Health Organization, type 2 diabetes is becoming increasingly more common in children and young adults. However, because the disease often goes undiagnosed and studies to assess the number of newly occurring cases are complicated, there is very little data on its true incidence.2 In the U.S., it is estimated that type 2 diabetes accounts for approximately half of all new cases of diabetes in adolescents and a third of these cases are undiagnosed.3

Indications and Usage

What is Victoza®?
Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine used:

  • along with diet and exercise to lower blood sugar (glucose) in adults and children who are 10 years of age and older with type 2 diabetes mellitus
  • to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease.

Victoza® is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if Victoza® can be used with mealtime insulin.
It is not known if Victoza® is safe and effective to lower blood sugar in children under 10 years of age.

About Victoza®
Victoza® (liraglutide) injection is a human glucagon-like peptide-1 (GLP-1) receptor agonist that is approved by the U.S. Food and Drug Administration as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes, and to reduce the risk of major adverse cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes with known heart disease.1 Victoza® is commercially available in more than 100 countries, treating more than 1.2 million people with type 2 diabetes globally.

About ELLIPSE
ELLIPSE (NCT01541215) is a phase 3, randomized, placebo-controlled, parallel group, multinational trial in which 135 children and adolescents 10-17 years of age were randomized 1:1 to treatment with Victoza® (liraglutide) injection up to 1.8 mg/day or placebo, in combination with metformin, with or without basal insulin, and diet and exercise for a 26-week, double-blind period, followed by a 26-week open label extension (total 52 weeks).1

About Novo Nordisk 
Novo Nordisk is a global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in four states, Novo Nordisk employs approximately 5,000 people throughout the country. For more information, visit novonordisk.us, Facebook and Twitter.

References

  1. Tamborlane WV, Barrientos-Perez M, Fainberg U, et al. Liraglutide in Children and Adolescents with Type 2 Diabetes. New England Journal of Medicine. 2019.
  2. World Health Organization. Global Report on Diabetes. Available at: http://apps.who.int/iris/bitstream/10665/204871/1/9789241565257_eng.pdf Last accessed: May 2019.
  3. Demmer RT, Zuk AM, Rosenbaum M, et al. Prevalence of diagnosed and undiagnosed type 2 diabetes mellitus among US adolescents: results from the continuous NHANES, 1999-2010. American Journal of Epidemiology. 2013;178:1106-1113.

SOURCE: Novo Nordisk

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