GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA dry powder inhaler.
The NDA is for FF monotherapy (100mcg and 200mcg doses) to be used as a once-daily inhaled dry powder maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
Starting 2014, regulatory filings for FF monotherapy are also planned to be submitted in other countries.
According to the company, FF administered using the ELLIPTA dry powder inhaler is an investigational medicine and is not currently approved anywhere in the world.
Earlier this month, GSK and Genmab have submitted a supplemental Biologics License Application (sBLA) to FDA for the use of its leukaemia drug Arzerra (ofatumumab) in combination with an alkylator-based therapy.
The combination drug will be used to treat chronic lymphocytic leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.
