GlaxoSmithKline (NYSE:GSK) won FDA approval for the use of its Arnuity Ellipta inhaler as a once-daily therapy for the maintenance treatment of asthma in children as young as five years old.
The pharmaceutical company touted its regulatory win, pointing out that the fluticasone furoate treatment is one of the only once-daily asthma therapies cleared in the U.S. for use in this age group.
Arnuity Ellipta, an inhaled corticosteroid, was approved by the FDA in August of 2014 for the maintenance treatment of asthma in kids ages 12 and up.
The company’s latest approval was supported by data from a 593-participant pivotal trial, which evaluated the safety and efficacy of once-daily fluticasone furoate in asthma patients ages 5 to 11. The 12-week study’s primary endpoint was the mean change from baseline in daily morning peak expiratory flow – a measure that demonstrates lung function.
Data from the trial found that patients using Arnuity Ellipta experienced statistically significant improvements in their peak expiratory flow compared to patients taking a placebo, according to GSK. The therapy’s safety profile was consistent with results from earlier trials, the company added.
“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,” Dr. Hal Barron, chief scientific officer & president of GSK’s R&D unit, said in prepared remarks.
