Against the backdrop of challenges for its Type 2 diabetes Bydureon business, AstraZeneca has received some good news from the FDA. The U.S. regulatory agency green lit the therapy in children, making Bydureon BCise the first once-weekly GLP-1 drug approved in the population.
AstraZeneca received FDA approval for the BCise version of its Bydureon product in adults in 2017. The injectable BCise formulation uses a continuous-release microsphere delivery system to provide patients with consistent levels of the active ingredient, exenatide, on a once-weekly dosing schedule. Now, the FDA has expanded the approval to cover children aged 10 years and up.
The new approval for the extended-release drug provides a point of differentiation for AstraZeneca in the competitive GLP-1 market. Novo Nordisk received FDA approval for its rival drug Victoza in children in 2017 but only on a daily dosing schedule. Trulicity, Eli Lilly’s once-weekly GLP-1 drug, is yet to win approval in children.
A phase 3 trial of Trulicity in children passed its primary completion last month, with full completion of the study scheduled for January, but for now AstraZeneca has an untapped opportunity to itself.
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AstraZeneca will pursue the opportunity as its broader Bydureon business faces hurdles. Last year, Bydureon sales fell 18%. AstraZeneca attributed the drop in sales in the U.S., the main market for Bydureon, to “competitive pressures and the impact of managed markets.” The product line grew slightly in the first quarter of 2021 to bring in sales of $103 million.
AstraZeneca won approval in children on the strength of a phase 3 clinical trial that tested the drug in 82 patients aged 10 to 17 years. The 28-week trial linked Bydureon BCise to a significantly greater mean change in average blood glucose from baseline compared to placebo. Adverse reactions in the pediatric population were similar to those seen in adults.