GlaxoSmithKline plc (GSK) has submitted a new drug application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the Ellipta dry powder inhaler.
Regulatory filings for FF monotherapy are planned in other countries from 2014 onwards. FF administered using the Ellipta dry powder inhaler is an investigational medicine and is not currently approved anywhere in the world.
The NDA has been submitted to the US Food and Drug Administration (FDA) for FF monotherapy (100mcg and 200mcg doses) as a once-daily inhaled dry powder maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
Ellipta is a trademark of the GSK group of companies.