AstraZeneca’s BYDUREON BCise (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control in pediatric patients (10 to 17 years) as an adjunct to diet and exercise. The approval by the US Food and Drug Administration (FDA) is the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in this population, supported by the positive results of the BCB114 Phase III trial in youth with T2D between 10 and <18 years of age; which showed on top of standard of care exenatide extended-release significantly improved glycemic control compared to placebo in pediatrics. This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D. The approval is an important development in diabetes care for this specific group of patients as the only non-insulin options for adolescents are metformin and liraglutide. BYDUREON BCise (exenatide extended-release) was first approved in the US in October 2017 as a once-weekly single-dose autoinjector device for adults with T2D whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control. It was also approved for use in the EU in August 2018. BCB114 was a 24-week, randomized, double-blind, placebo-controlled Phase III trial with a 28-week open-label extension. Pediatric patients aged 10 to 17 years (N=82) with T2D treated with diet and exercise alone or in combination with a stable dose of oral antidiabetic agents and/or insulin were randomized to receive exenatide extended-release 2 mg or placebo. The primary efficacy endpoint of the Phase III trial was change in glycated hemoglobin A1c (HbA1c) from baseline to week 24. Results demonstrated that patients administered exenatide extended-release achieved a significantly greater mean change in HbA1c from baseline compared to placebo (-0.25%, n=58, baseline A1C 8.13% vs +0.45%, n=24, baseline A1C 8.28%, respectively; p<0.05).