
FDA approves Novo Nordisk’s Victoza for children with type 2 diabetes
pharmafile | June 18, 2019 | News story | Manufacturing and Production | GLP-1, Novo Nordisk, Victoza, diabetes, liraglutide
The FDA has approved Novo Nordisk’s Victoza (liraglutide) for paediatric patients aged 10 years and older with type 2 diabetes.
The drug is the first non-insulin drug approved to treat paediatric patients with type 2 diabetes since metformin was approved in 2000.
The injectable diabetes drug has however been available to adult patients since 2010.
Victoza, a glucagon-like peptide (GLP-1) receptor aganoist, works by creating the same effects as the GLP-1 receptor protein in the pancreas thus increasing insulin release from the pancreas and decreasing excessive glucagon release.
Dr Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research commented: “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.”
The drug was shown to be safe and effective in several placebo-controlled trials in adults and one placebo-controlled trial of 134 paediatric patients aged 10 and older.
Louis Goss
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