FDA approves BYDUREON BCise for treatment of type 2 diabetes

The US Food and Drug Administration has approved AztraZeneca’s BYDUREON BCise (exenatide extended-release) once-weekly injectable suspension for use in children aged 10 to 17 years for the treatment of type 2 diabetes.¹ The treatment should be used in addition to a diet and exercise plan.

The approval is passed on a 24-week, randomized, double-blind, placebo-controlled phase III trial, which had a 28-week open-label extension. The 82 participants who were treated with diet and exercise alone or in combination with oral antidiabetic agents and/or insulin were randomly placed into a treatment arm where they received exenatide extended-release 2 mg on into the control arm where they received a placebo. The primary endpoint for efficacy was change in glycated hemoglobin A1c (HbA1c) from baseline to the 24th week. The investigators found that children in the treatment arm had a significantly larger mean change in HbA1c when compared to the placebo group (-0.25%, n=58, baseline A1c 8.13% vs + 0.45%, n = 24, baseline A1c 8.28%, respectively; p <0.05).

The adverse events noted in the trial were similar to those seen in the adult population. The most common events were an injection site nodule and nausea. It’s not recommended for use a first-line therapy in children who are inadequately controlled on diet and exercise and should not be use with other exenatide-containing products. For patients with a history of pancreatitis, other therapies should be considered first.

Reference

1. AstraZeneca. BYDUREON BCise (exenatide extended-release) approved in the US for the treatment of type 2 diabetes in pediatric patients ages 10 years and older. Published July 23, 2021. Accessed July 23, 2021. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2021/bydureon-bcise-exenatide-extended-release-approved-in-the-us-for-the-treatment-of-type-2-diabetes.html