The Food and Drug Administration (FDA) has expanded the approval of Bydureon BCise (exenatide extended-release) injection to include patients 10 years of age and older with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. The treatment was previously approved only in adults.
The expanded approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (ClinicalTrials.gov Identifier: NCT01554618) that evaluated the efficacy and safety of exenatide extended-release, a glucagon-like peptide-1 (GLP-1) receptor agonist, for glycemic control in 82 patients aged 10 to 17 years with type 2 diabetes. Patients were randomly assigned 2:1 to receive exenatide extended-release 2mg subcutaneously once weekly (n=58) or placebo (n=24) for 24 weeks. The primary endpoint was the reduction in hemoglobin A1c (HbA1c).
Findings demonstrated that patients treated with exenatide extended-release achieved a mean HbA1c decrease of 0.25% at week 24 compared with a mean HbA1c increase of 0.45% for those treated with placebo (total mean difference -0.70%; P <.05).
The safety profile of exenatide extended-release in the pediatric population was similar to that observed in the adult population. The most common adverse reactions were injection site reactions, headaches, and gastrointestinal issues. Bydureon also carries a Boxed Warning regarding an increased risk of thyroid C-cell tumors.
The International Coordinating Investigator of the trial, William Tamborlane, MD, Department of Pediatrics, Yale School of Medicine, said: “The US FDA approval is an important milestone for the treatment of children with type 2 diabetes. Bydureon BCise brings an important new therapeutic option to physicians caring for children with this chronic disease that can lead to serious long-term issues if not adequately treated.”
Bydureon BCise is available as a prefilled single-dose autoinjector containing 2mg of exenatide extended-release injectable suspension in 4-count cartons.
- FDA approves treatment for pediatric patients with type 2 diabetes. News release. US Food and Drug Administration. Accessed July 22, 2021. https://content.govdelivery.com/accounts/USFDA/bulletins/2e98d66.
- Bydureon BCise (exenatide extended-release) approved in the US for the treatment of type 2 diabetes in pediatric patients ages 10 years and older. News release. AstraZeneca. Accessed July 23, 2021. https://www.businesswire.com/news/home/20210723005083/en/BYDUREON-BCise-exenatide-extended-release-Approved-in-the-US-for-the-Treatment-of-Type-2-Diabetes-in-Pediatric-Patients-Ages-10-Years-and-Older.