The FDA approved an expanded indication for extended-release exenatide (Bydureon and Bydureon BCise) to improve glycemic control in pediatric patients ages 10-17 years with type 2 diabetes (T2D).
The once-weekly, subcutaneously-administered glucagon-like peptide-1 receptor agonist (Byetta) was initially approved in 2005 as an adjunct to diet and exercise for adults with T2D. These two extended-release versions of exenatide, an injectable suspension (Bydureon) and an autoinjector (Bydureon BCise), were approved in 2012 and 2017, respectively.
This new pediatric indication for exenatide was based on results from the phase III, 24-week, double-blind, placebo-controlled BCB114 study, which pitted exenatide extended release (2 mg) plus diet and exercise against diet and exercise alone in a cohort of 82 patients ages 10-17 years with T2D, according to a press release from the drug’s manufacturer.
The study’s primary efficacy endpoint was change in glycated hemoglobin A1c (HbA1c) from baseline to week 24, the manufacturer explained. “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% versus +0.45%, n=24, baseline A1C 8.28%, respectively; P<0.05).” The adverse events observed in the pediatric population were consistent with those observed among adults, the company added.
Exenatide’s prescribing information included a boxed warning due to an increased risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), among patients taking the drug. Patients who have had or who have a family history of MTC should not use this therapy, the FDA warned. Also, patients with multiple endocrine neoplasia syndrome type 2, patients with prior history of serious allergic reactions to exenatide or its components, and patients with a history of drug-induced mediated thrombocytopenia should not take the drug.
Exenatide also carries warnings regarding increased risk of pancreatitis, hypoglycemia (when used with insulin or insulin secretagogues), acute kidney injury, gastrointestinal disease, immunogenicity, anaphylaxis, thrombocytopenia, and acute gallbladder disease. Common side effects include injection site reactions, headaches, and gastrointestinal issues.
Exenatide is manufactured by AstraZeneca.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 138
Topic ID: 85,138,730,12,13,138,669,725,918
