A phase 3 clinical trial of AstraZeneca’s extended-release diabetes drug Bydureon in adolescents has met its primary endpoint. The study tested a once-weekly formulation of the glucagon-like peptide-1 receptor agonist exenatide to support a planned filing for approval with the FDA.
Amylin Pharmaceutical and Eli Lilly first won approval for the Byetta-branded version of exenatide in 2005, before going on to get clearance to sell extended-release formulation Bydureon in 2012. Now, AstraZeneca, which was part of a deal to buy Amylin in 2012, has generated data that could support the expansion of the Bydureon label to cover people aged 10 to 17 years with type 2 diabetes.
Investigators randomized 83 adolescents to receive Bydureon or placebo once weekly. At 24 weeks, Bydureon significantly reduced blood sugar measure HbA1c from baseline compared with placebo. The p-value was 0.012, causing the study to hit its primary endpoint.
AstraZeneca said the drug was generally well-tolerated, with the study revealing a safety profile that is in keeping with that seen in adults. Upper respiratory tract infections affected 10% of patients in the Bydureon arm. Gastrointestinal disorders were more common in the placebo group, 26%, than the Bydureon arm, 22%.
Yale School of Medicine’s William Tamborlane, the international coordinating investigator of the trial, set out the need for Bydureon in adolescents, explaining that an obesity-linked rise in type 2 diabetes in younger people has exposed a gap in the treatment toolkit.
“It is particularly noteworthy that no once-weekly injection of a GLP-1 receptor agonist has been approved for older children or adolescents with T2D by the US Food and Drug Administration. Consequently, once-weekly injections of exenatide could fill that gap in treatment options for T2D patients in this age group,” Tamborlane said in a statement.
AstraZeneca, which has priority review from the FDA, is now working to get the extended-release exenatide formulation approved in adolescents. The update, which AstraZeneca shared at the 2021 American Diabetes Association Virtual 81st Scientific Sessions, follows a long wait. The phase 3 trial began in December 2011 but, according to ClinicalTrials.gov, only recently wrapped up.