FDA Approves Victoza for Type 2 Diabetes in Children and Adolescents

Novo Nordisk announced 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.

"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," said 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. 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.

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