The US Food and Drug Administration (FDA) has expanded the use of the inhaled corticosteroid fluticasone furoate (Arnuity Ellipta, GlaxoSmithKline) as a once-daily asthma maintenance treatment for children as young as age 5 years.
"Despite the challenges of running clinical studies in this age group, we felt it was important to conduct a study to confirm the benefit of Arnuity in improving lung function in younger children with asthma — giving doctors confidence when choosing to prescribe this treatment for children as young as 5 years old," Hal Barron, MD, chief scientific officer and president of Research & Development at GlaxoSmithKline, said in a news release.
Arnuity Ellipta (100 and 200 μg) was approved in the United States in August 2014 for the maintenance treatment of asthma in patients aged 12 years and older.
Approval of Arnuity Ellipta (50 μg) in children aged 5 to 11 years was supported by data from a trial that assessed the efficacy and safety of once-daily dosing vs placebo in 593 children with asthma. Inhaled fluticasone propionate at 100 μg twice daily was included as an active control.
The primary endpoint of the 12-week study was the mean change from baseline in daily morning peak expiratory flow (PEF). Results showed statistically significant improvements in PEF with Arnuity Ellipta over placebo (19.5 L/min; P < .001).
The safety profile of Arnuity Ellipta in children 5 to 11 years old is consistent with the known safety profile of the drug, the company said. The most common adverse reactions reported in children are pharyngitis, bronchitis, and viral infection.
Arnuity Ellipta is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any ingredients of Arnuity Ellipta.
Candida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta. Patients should rinse their mouth with water without swallowing after inhalation.