It is the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the indicated population
The FDA approval is based on positive results from the Phase 3 BCB114 trial. (Credit: dorofeevajana from Pixabay)
AstraZeneca has received the US Food and Drug Administration (FDA) approval for Bydureon BCise (exenatide extended-release) to treat type 2 diabetes (T2D) in children.
The drug, administered as once-weekly injection, is indicated for improving glycaemic control in paediatric patients aged 10 to 17 years, as an adjunct to diet and exercise.
It is the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in the indicated population, said the company.
In October 2017, Bydureon BCise was initially approved in the US as a once-weekly single-dose autoinjector device to treat adults with T2D, and in the EU, in August 2018.
The drug was intended to improve glycemic control in T2D patients whose blood sugar cannot be controlled on one or more oral medicines, in addition to diet and exercise.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “This decision is an important milestone for the care of this younger patient population by providing a convenient, once-weekly treatment option.
“The Phase 3 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.”
The FDA approval is based on positive results from the Phase 3 BCB114 trial, in T2D patients aged between 10 and 18 years.
The Phase 3 trial showed that Bydureon BCise, in addition to standard of care significantly improved glycaemic control compared to placebo.
According to AstraZeneca, the FDA approval is an important development in diabetes care for this patient population as the only non-insulin options are metformin and liraglutide.
The primary efficacy endpoint of the study was change in glycated hemoglobin A1c (HbA1c) from baseline to week 24.
Results from the Phase 3 study showed that patients treated with Bydureon BCise experienced a higher change in HbA1c from baseline compared to placebo.
The adverse reactions observed in the paediatric population were consistent with that observed in the adult population.
AstraZeneca said that the safety and effectiveness of exenatide extended-release have not been established in paediatric patients less than 10 years of age.
The drug is not advised for patients with a personal or family history of medullary thyroid carcinoma (MTC), or with multiple endocrine neoplasia syndrome type 2 (MEN 2).