GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma

GSK

21 May 2018 - GSK today announced it has received approval from the US FDA for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid medicine for the maintenance treatment of asthma in children from as young as 5 years. 

This makes Arnuity one of the few once-daily treatments for asthma licenced in the US in this younger age group, where there remains a significant need for convenient and effective treatment options.

The submission to support today’s approval included data from a pivotal study assessing the efficacy and safety of once daily fluticasone furoate, compared with placebo, in 593 children aged 5 to 11 years (inclusive) with asthma. Inhaled fluticasone propionate 100 mcg twice daily was included as an active control.

Read GSK press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics