FDA approves use of Arnuity Ellipta for maintenance treatment of asthma in children from 5 years.- GlaxoSmithKline.

GlaxoSmithKline has received approval from the FDA for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance treatment of asthma in children from as young as 5 years. This makes Arnuity one of the few once-daily treatments for asthma licenced in the US in this younger age group, where there remains a significant need for convenient and effective treatment options.

The submission to support today’s approval included data from a pivotal study assessing the efficacy and safety of once daily fluticasone furoate, compared with placebo, in 593 children aged 5 to 11 years (inclusive) with asthma. Inhaled fluticasone propionate 100 mcg 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), a measure of lung function. Results showed statistically significant improvements in PEF with once daily fluticasone furoate 50mg over placebo. The safety profile in this age group was consistent with the known profile of Arnuity (incidence of on-treatment adverse events (ITT population) was 29% in the placebo group and 32% in the fluticasone furoate 50mcg group). Most common adverse reactions reported in at least 3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.

Comment: Arnuity Ellipta (100mcg and 200mcg) is an inhaled corticosteroid (ICS) which was approved in the US in August 2014 for the maintenance treatment of asthma in patients aged 12 years and older.