US clears paediatric use of GSK’s Arnuity Ellipta

US regulators have issued a green light for the once-daily inhaler as maintenance treatment of asthma in children from as young as five years.

The submission was supported by data from a pivotal study pitting the efficacy and safety of Arnuity Ellipta (fluticasone furoate) against placebo in 593 children aged 5 to 11 years (inclusive) with asthma.

Results showed statistically significant improvements in peak expiratory flow with the once daily inhaler over placebo of 19.5 L/min. Also, the safety profile in this age group "was consistent with the known profile of Arnuity", GSK noted, with the most common adverse reactions reported pharyngitis, bronchitis, and viral infection.

"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," said Hal Barron, the firm’s chief scientific officer and president of R&D.

GSK's dry powder inhaler Ellipta is being used to deliver a variety of therapies for asthma and chronic obstructive pulmonary disease around the globe.

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