24 July 2017 - GSK today announced the filing of a supplementary new drug application to the US FDA for the use of Arnuity Ellipta (fluticasone furoate) as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years (inclusive). 

The application is seeking approval for a dose of 50 mcg once-daily, delivered using the Ellipta inhaler in this group of patients.

Today’s submission includes data from a pivotal study assessing the efficacy and safety of once daily fluticasone furoate, compared to placebo, in 593 children aged 5 to 11 years (inclusive) with asthma. The primary endpoint of the 12-week study was the mean change from baseline in daily morning peak expiratory flow.

Read GSK press release