FDA Approves Pediatric Type 2 Diabetes Treatment

The U.S. FDA approved Bydureon and Bydureon BCise (exenatide extended-release) injection to be used in addition to diet and exercise to improve glycemic control (blood sugar levels) in pediatric patients 10 years or older with type 2 diabetes. Exenatide extended-release was previously approved to treat adults with type 2 diabetes.

Exenatide extended-release is not recommended as a first treatment option for patients whose disease is not adequately controlled through diet and exercise. The medication should not be used for type 1 diabetes. Exenatide extended-release should not be used with other exenatide-containing products and it has not been studied in patients with a history of pancreatitis (inflammation of the pancreas).

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 adults, the prevalence among younger people has been rising over the past few decades. The Centers for Disease Control and Prevention estimates that nearly 6,000 new cases of type 2 diabetes are diagnosed each year among U.S. youth aged 10-19.

Exenatide extended-release improves blood sugar levels by creating similar effects in the body as the glucagon-like peptide (GLP-1) protein in the pancreas. GLP-1 levels are often insufficient in patients with type 2 diabetes. Like GLP-1, exenatide-extended release slows digestion, prevents the liver from making too much glucose (a simple sugar), and helps the pancreas produce more insulin when needed.