GSK announced the filing of a supplementary New Drug Application (sNDA) to the US Food and Drug Administration (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 sNDA is seeking approval for a dose of 50mcg once-daily, delivered using the Ellipta inhaler in this group of patients.
Arnuity Ellipta (fluticasone furoate 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.
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 (PEF).1
Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide.
The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment.
Study design (HZA106855)
In the pivotal study (HZA106855) 593 children were randomized to receive either placebo once daily, fluticasone propionate 100mcg twice daily, or fluticasone furoate 25mcg, 50mcg, or 100mcg once daily. The primary endpoint of the 12-week study was the mean change from baseline in daily morning peak expiratory flow (PEF). None of the doses studied are currently approved for use in children aged 5 to 11 years.
Filed Under: Drug Discovery