GSK has filed a supplementary NDA for approval of a 50mcg once-daily dose of the Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11. The FDA approved 100mcg and 200mcg doses of Arnuity Ellipta for the treatment of asthma in patients aged 12 and over in August 2014.
According to GSK, the sNDA includes data from a 12-week efficacy and safety study of fluticasone furoate vs placebo that enrolled 593 asthma patients aged 5-11.
Read the GSK press release.
