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.Liraglutide powder
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.
