The Food and Drug Administration (FDA) has expanded the approval of Victoza (liraglutide; Novo Nordisk) to include treatment of pediatric patients ≥10 years old with type 2 diabetes (T2D).
The approval of Victoza in this patient population was based on data from the ELLIPSE trial which included 134 children and adolescents 10 to <17 years of age with T2D. Patients were randomly assigned to receive up to 1.8mg of liraglutide daily or placebo in addition to metformin (+/- basal insulin).
Results showed that after 26 weeks, patients who received liraglutide experienced a mean glycated hemoglobin level decrease of 0.64 percentage points while placebo patients experienced an increase of 0.42 percentage points, correlating to a treatment difference of -1.06 percentage points (P <.001). By 52 weeks, the treatment difference was found to increase to -1.30 percentage points.
With regard to safety, the risk of hypoglycemia was found to be higher with Victoza in pediatric patients regardless of concomitant antidiabetic therapies.
“Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes,” said Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”
Victoza, a glucagon-like peptide-1 (GLP-1) receptor agonist, is already approved for the treatment of T2D in adults and is also indicated to reduce the risk of major adverse cardiovascular events (MACE) in adults with T2D and established cardiovascular disease; the effects of Victoza on MACE in pediatric patients has not been studied and it is not indicated for this use in children.
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