Novo Nordisk has secured approval for Victoza (liraglutide) from the US Food and Drug Administration (FDA) to treat paediatric patients aged ten years or older with type 2 diabetes.
Victoza is claimed to be the first non-insulin drug approved to treat the condition in paediatric patients. It has been used for adult patients since 2010.
Acting director at the FDA Center for Drug Evaluation and Research’s Division of Metabolism and Endocrinology Products (DMEP) Lisa Yanoff said: “Victoza has now been shown to improve blood sugar control in paediatric patients with type 2 diabetes.
“The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease.”
When administered, Victoza works by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas and improves blood sugar levels.
Victoza slows digestion, prevents the liver from making too much glucose, and helps the pancreas produce more insulin when needed.
It can also be used to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes and established CV disease.
Novo Nordisk carried out several placebo-controlled trials in adults and one placebo-controlled trial with 134 pediatric patients to evaluate the efficacy and safety of Victoza for reducing blood sugar in patients with type 2 diabetes.
The drug is not a substitute for insulin and is not indicated for patients with type 1 diabetes or those with diabetic ketoacidosis. No clinical trials were conducted to study the effect of the drug on major adverse CV events in paediatrics.