Type 2 diabetes treatment approved for children and adolescents
The FDA has approved an injection for use in patients aged 10-17 to treat type 2 diabetes.
The US Food and Drug Administration (FDA) has approved the expanded indication for the Victoza® (liraglutide) injection to include children and adolescents aged 10-17 years. The treatment lowers blood sugar in patients with type 2 diabetes.
The update is based on results from a global ELLIPSE trial, the first Phase III trial completed in over a decade in children and adolescents with type 2 diabetes. In this study, patients were randomised to receive either up to 1.8 mg/day of liraglutide or placebo, in combination with metformin with or without basal insulin over a 26-week double-blinded period. This was followed by a 26-week open-label extension period.
The injection mimics the effects of the glucagon-like peptide (GLP-1) receptor protein in the pancreas so improves blood sugar levels. It provides an option other than metformin and insulin for the first time in 19 years and is intended to be taken along with changes to diet and exercise. The treatment, developed by Novo Nordisk, was first approved for use in 2010 for adults with type 2 diabetes.
“The prevalence of type 2 diabetes in the US 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,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.