Exenatide extended-release represents the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) for pediatric patients with type 2 diabetes.
The US Food and Drug Administration (FDA) has approved exenatide extended-release (Bydureon BCise) for the treatment of type 2 diabetes in patients between 10-17 years old.
The once-weekly injectable suspension is aimed at improving glycemic control in pediatric patients as an adjunct to diet and exercise.
The approval, awarded to AstraZeneca, is the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) for pediatric patients with type 2 diabetes.
In the BCB114 phase 3 study, the treatment added to standard of care, resulted in a significant improvement of glycemic control compared to placebo for pediatric patients.
In the randomized, double-blind, placebo-controlled trial, the researchers met the primary efficacy endpoint of the change in glycated hemoglobin A1c (HbA1c) from baseline to week 24.
The team found patients in the treatment arm had a significantly greater mean change in HbA1c from baseline 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).
For safety, adverse events in the pediatric population was consistent with what was previous found in adults.
“This decision is an important milestone for the care of this younger patient population by providing a convenient, once-weekly treatment option,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said in a statement. “The Phase III data that supported this approval demonstrated the safety and tolerability of exenatide extended-release in younger patients was similar to the proven safety profile of this medicine in adults.”
Exenatide extended-release was first approved in the US in 2017 as a once-weekly single-dose autoinjector device for adults with type 2 diabetes and uncontrolled blood sugar on 1 or more oral medicines.