GSK files supplementary NDA for asthma treatment arnuity ellipta


GSK has submitted a supplementary New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of arnuity ellipta (fluticasone furoate) as a maintenance treatment of children with asthma.

Asthma is a chronic lung disease that inflames and narrows the airways. The disease affects 358 million people across worldwide.

Fluticasone furoate (100mcg and 200mcg) is an inhaled corticosteroid (ICS) that can be used as a prophylactic therapy in children aged five to 11 (inclusive).

GSK has filed the sNDA to seek FDA approval for a once-daily dose of 50mcg that can be administered to this group of patients using the company’s Ellipta inhaler.

In August 2014, arnuity ellipta was approved in the US for the maintenance treatment of asthma in patients aged 12 and older.

"GSK has filed the sNDA to seek FDA approval for a once-daily dose of 50mcg that can be administered to this group of patients using the company’s Ellipta inhaler."

The current submission includes data from a major study (HZA106855) that assessed the efficacy and safety of once daily fluticasone furoate, compared to placebo.

The 12-week study involved 593 children with asthma who were randomised to receive either placebo once daily, fluticasone propionate at 100mcg twice daily or fluticasone furoate at 25mcg, 50mcg, or 100mcg once daily.

The primary endpoint of the study was the mean change from baseline in daily morning peak expiratory flow (PEF).

The most common adverse reactions reported in greater than or equal to 5% of patients administered with arnuity ellipta were upper respiratory tract infection, nasopharyngitis, headache and bronchitis.


Image: GSK House in Brentford, London, UK. Photo: courtesy of GlaxoSmithKline via Flickr.com.