The US Food and Drug Administration (FDA) has approved AstraZeneca’s Bydureon BCise (exenatide extended-release) to enhance glycaemic control in paediatric patients aged ten to 17 years with type 2 diabetes (T2D).
Indicated as an adjunct to diet and exercise, Bydureon BCise is a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA).
In October 2017, Bydureon BCise received approval in the US for use in adults with T2D.
AstraZeneca noted that the injectable therapy is the first once-weekly GLP-1 RA to obtain regulatory approval for paediatric patients with T2D.
The expanded approval is based on positive data from a randomised, double-blind, placebo-controlled Phase III BCB114 trial conducted in 82 T2D patients aged ten to 17 years.
Trial subjects treated with diet and exercise alone or along with a stable dose of oral antidiabetic agents and/or insulin were categorised to be given exenatide extended-release 2mg or placebo.
The change in glycated haemoglobin A1c (HbA1c) from baseline to 24 weeks was the trial’s primary efficacy goal.
According to the trial results, subjects receiving exenatide extended-release had a substantially higher mean change in HbA1c from baseline as against placebo.
Furthermore, the therapy when given along with the standard of care sustainably enhanced glycaemic control versus placebo in paediatric subjects.
The adverse reactions noted in these subjects were comparable to those reported in adults.
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 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.”
The latest approval is significant in adolescent diabetic care as metformin and liraglutide are the only non-insulin options currently available, the company noted.
National Medical Products Administration in China approved AstraZeneca’s Imfinzi (durvalumab) as the first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC) in adults, earlier last week.