Fluticasone Furoate Gets FDA Approval for Pediatric Asthma Maintenance


The inhaled corticosteroid from GSK is indicated for pediatric asthma patients aged 5-11 years old.

The US Food and Drug Administration (FDA) has approved once-daily inhaled corticosteroid (ICS) fluticasone furoate (Arnuity Ellipta) for the maintenance treatment of children from 5 years old with asthma.

The therapy, from GlaxoSmithKline (GSK), now joins a small list of once-daily therapies licensed in the country for this particular pediatric asthma population — a space still in need of more convenient treatment options, according to GSK.

Its approval as a prophylactic maintenance therapy in children aged 5-11 years was supported by data from a pivotal trial that assessed the efficacy and safety of once-daily fluticasone furoate (FF) versus placebo in 593 children with asthma. Researchers included inhaled fluticasone propionate 100 mcg twice daily as an active control, as well.

The 12-week study (HZA106855) randomized children to receiver either once-daily FF 25 mcg, 50 mcg, or 100 mcg, fluticasone propionate 100 mcg twice-daily, or placebo once-daily. Researchers sought a primary endpoint of mean change from baseline in daily morning peak expiratory flow (PEF), to gauge lung function improvement.

Patients reported statistically significant improvements in PEF with once-daily FF 50 mg versus patients administered placebo (19.5 L/ min; P < 0.001). Patients also reported a safety profile consistent with the already-known profile of FF — on-treatment adverse events were reported in 32% of FF 50 mg patients and 29% of placebo patients.

The most commonly reported adverse reactions reported in at least 3% of the patients aged 5-11 years were pharyngitis, bronchitis, and viral infection.

Hal Barron, MD, chief scientific officer and president of Research & Development at GSK, said the therapy brings a new form of convenience and comfort to both patients and physicians.

“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,” Barron said in a statement.

Arnuity Ellipta is indicated to be administered to patients via GSK’s Ellipta brand inhaler. At the 2018 American Thoracic Society (ATS) International Conference in San Diego, CA, GSK presented new data for its once-daily triple-drug inhaler fluticasone furoate/ umeclidinium/vilanterol (Trelegy Ellipta) which showed positive benefit-risk ratios in a phase 3 pivotal trial that compared it to dual therapies for adult patients with chronic obstructive pulmonary disease (COPD).

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