FDA Approves First Weekly Injectable Suspension Type 2 Diabetes Treatment in Certain Pediatric Populations

A once-weekly injectable suspension has been approved in the U.S. for the treatment of type 2 diabetes. Marketed by AstraZeneca as BYDUREON BCise (exenatide extended-release), it has been shown to 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 type 2 diabetes 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 type 2 diabetes. 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.

“This decision is an important milestone for the care of this younger patient population by providing a convenient, once-weekly treatment option,” says Mene Pangalos, executive vice president, BioPharmaceuticals R&D. “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.”

Nearly four decades ago, type 2 diabetes in children was considered rare, but the global rate has been increasing since the mid-1990s, particularly in the U.S., as the percentage of children who are overweight or obese has risen.

The FDA approval is an important milestone for the treatment of children with type 2 diabetes, according to the international coordinating investigator of the trial, William Tamborlane, MD, Department of Pediatrics, Yale School of Medicine. “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,” he adds.

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 type 2 diabetes 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 type 2 diabetes 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).

Overall, the adverse reactions observed in this pediatric population were consistent with that observed in the adult population. Safety and effectiveness of exenatide extended-release have not been established in pediatric patients less than 10 years of age.

 

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