FDA approves new treatment for pediatric patients with type 2 diabetes

FDA on Monday approved liraglutide (Victoza—Novo Nordisk) injection for the treatment of pediatric patients aged 10 years or older with types 2 diabetes. The non-insulin drug has been approved to treat adults with type 2 diabetes for nearly a decade.

FDA on Monday approved liraglutide (Victoza—Novo Nordisk) injection for the treatment of pediatric patients aged 10 years or older with types 2 diabetes. The non-insulin drug has been approved to treat adults with type 2 diabetes for nearly a decade. "Victoza has now been shown to improve blood sugar control in pediatric patients with type 2 diabetes," said Lisa Yanoff, MD, acting director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research. "The expanded indication provides an additional treatment option at a time when an increasing number of children are being diagnosed with this disease." Liraglutide's prescribing information includes a boxed warning about a higher risk of thyroid C-cell tumors. Because of this, patients who have had, or have family members who have ever had medullary thyroid carcinoma, should not use liraglutide, nor should patients with multiple endocrine neoplasia syndrome type 2. The drug also carries warnings about pancreatitis, Victoza pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia, renal impairment or kidney failure, hypersensitivity, and acute gallbladder disease. The most common adverse effects are nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation. FDA granted this application Priority Review.