AstraZeneca’s Bydureon OK’d for Pediatric Diabetics

FDA has approved AstraZeneca’s Bydureon and Bydureon BCise (exenatide extended-release) injection for use in addition to diet and exercise to improve glycemic control in pediatric patients 10 years or older with Type 2 diabetes. Previously, the drug was approved for treating adults with Type 2 diabetes.

Approval was based on data from a 24-week, placebo-controlled study in pediatric patients 10 years or older. At week 24, patients receiving exenatide extended-release had an average 0.25% decrease in blood glucose measurements, whereas patients receiving the placebo had an average 0.45% increase, an FDA release says.

The agency says exenatide extended-release is not recommended as a first treatment option for patients whose disease is not adequately controlled through diet and exercise. It should also not be used for Type 1 diabetes.