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Monday, June 17, 2019

FDA OKs non-insulin Type 2 diabetes drug for kids, first to hit market in 20 years

The U.S. Food and Drug Administration on Monday approved Novo Nordisk’sNVO, +0.01% Victoza, a liraglutide injection, for the treatment of young patients 10 years or older with Type 2 diabetes. Although Victoza has been FDA-approved to treat adults with Type 2 diabetes since 2010, it is the only non-insulin drug approved for children other than metformin, which was approved for pediatric use in 2000. “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,” said Lisa Yanoff, acting director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. Type 2 diabetes occurs when the pancreas is unable to make enough insulin to keep blood sugar at normal levels. It’s the most common form of diabetes, normally occurring in patients 45 years or older. However, in the past two decades, its prevalence among younger patients has dramatically risen. More than 5,000 new cases of Type 2 diabetes are now diagnosed each year in the U.S. among people younger than age 20, according to the Centers for Disease and Control and Prevention.

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