21 May 2018 - GSK today announced it has received approval from the US FDA for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid 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.