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Officials with the FDA today approved liraglutide (Victoza, Novo Nordisk) injection for treatment of pediatric patients age 10 years or older with type 2 diabetes (T2D).
Officials with the FDA today approved liraglutide (Victoza, Novo Nordisk) injection for treatment of pediatric patients age 10 years or older with type 2 diabetes (T2D).
Liraglutide is the first noninsulin drug approved to treat T2D in pediatric patients since metformin was approved for pediatric use in 2000, according to the FDA. Liraglutide has been approved to treat adult patients with T2D 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, MD acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “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.”
Although T2D primarily occurs in patients over the age of 45 years, the prevalence rate among younger patients has been rising dramatically over the past couple of decades. The Diabetes Report Card published by the CDC estimates that more than 5000 new cases of T2D are diagnosed each year among people younger than age 20 years in the United States.
Liraglutide improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found in insufficient levels in T2D patients. Like GLP-1, liraglutide slows digestion, prevents the liver from making too much glucose, and helps the pancreas produce more insulin when needed.
For more on this approval, continue reading on Pharmacy Times.