GlaxoSmithKline announced that the FDA has approved Arnuity Ellipta, a once-daily inhaled corticosteroid, for treating asthma in children aged as young as 5 years, according to a company press release.
The action approves Arnuity Ellipta (fluticasone furoate) as maintenance prophylactic therapy in children aged 5 to 11 years through a 50 µg one-daily dose with the use of the Ellipta inhaler. Arnuity Elllipta 100 µg and 200 µg was approved in August 2014 as an inhaled corticosteroid for children aged 12 years and older with asthma.
“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 and development at GlaxoSmithKline, said in the release.
The FDA approval was based on data from a 12-week study of 593 children aged 5 to 11 years with asthma, in which they received fluticasone propionate 100 µg twice daily or fluticasone furoate 25 µg, 50 µg or 100 µg once daily or placebo once daily. Mean change from baseline in daily morning peak expiratory flow was the primary endpoint.
The cohort receiving once-daily fluticasone furoate 50 µg showed statistical significance compared with the placebo cohort (19.5 L/min: P < .001).
The safety profile was 32% in the fluticasone furoate 50 µg cohort and 29% in the placebo group, and was consistent with the known profile of Arnuity, according to the release.
Pharyngitis, bronchitis and viral infection were the most common adverse events associated with fluticasone furoate in at least 3% of patients aged 5 to 11 years, according to the release.