FDA backs treatment for pediatric patients with type 2 diabetes

23 July 2021

The US Food and Drug Administration yesterday approved Bydureon and Bydureon BCie (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.

Developed and marketed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN), exenatide extended-release was previously approved to treat adults with type 2 diabetes. First-quarter 2021 sales of Bydureon were $103 million.

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).

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