According to GSK, the FDA has approved the company’s sNDA for the use of Arnuity Ellipta fluticasone furoate DPI for the treatment of asthma in children aged 5-11 years. Arnuity Ellipta was approved by the FDA in 2014 for the treatment of asthma in patients 12 years old and older.
GSK submitted the sNDA for pediatric use in July 2017. The new approval is for a 50μg once-daily dose; the 2014 approval for use in patients 12 and older is for 100μg and 200μg doses of Arnuity Ellipta.
GSK Chief Scientific Officer and President of R&D Hal Barron commented, “Despite the challenges of running clinical studies in this age group, we felt it was important to conduct a study to confirm the benefit of Arnuity in improving lung function in younger children with asthma – giving doctors confidence when choosing to prescribe this treatment for children as young as 5 years old.”
Read the GSK press release.
