WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration Monday approved Novo Nordisk's Victoza injection for treatment of pediatric patients 10 years or older with type 2 diabetes.
Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult patients with type 2 diabetes since 2010.
'The FDA encourages drugs to be made available to the widest number of patients possible when there is evidence of safety and efficacy,' said Lisa Yanoff, M.D, acting director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.
'Victoza has now been shown to improve blood sugar control in pediatric 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.'
Type 2 diabetes is the most common form of diabetes, occurring when the pancreas cannot make enough insulin to keep blood sugar at normal levels. Although type 2 diabetes primarily occurs in patients over the age of 45, the prevalence rate among younger patients has been rising dramatically over the past couple of decades.
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