GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) 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.
Dr.Hal Barron, Chief Scientific Officer and President of R&D, GSK, said "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."
The approval is for the use of Arnuity Ellipta as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years, delivered as a 50mcg once-daily dose using the Ellipta inhaler. Arnuity is not indicated for relief of acute bronchospasm. Arnuity Ellipta (100mcg and 200mcg) is an inhaled corticosteroid (ICS) which was approved in the US in August 2014 for the maintenance treatment of asthma in patients aged 12 years and older.
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. The primary endpoint of the 12-week study was the mean change from baseline in daily morning peak expiratory flow (PEF), a measure of lung function.1 Results showed statistically significant improvements in PEF with once daily fluticasone furoate 50mg over placebo (19.5 L/min; P<.001). The safety profile in this age group was consistent with the known profile of Arnuity (incidence of on-treatment adverse events (ITT population) was 29% in the placebo group and 32% in the fluticasone furoate 50mcg group). Most common adverse reactions reported in ≥3% of pediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.
Study design (HZA106855)
In the pivotal study (HZA106855) 593 children were randomized to receive either placebo once daily, fluticasone propionate 100mcg twice daily, or fluticasone furoate 25mcg, 50mcg, or 100mcg once daily. The primary endpoint of the 12-week study was the mean change from baseline in daily morning peak expiratory flow (PEF).
About asthma
Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide.Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily life.
The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.
Important Safety Information
The following Important Safety Information is based on the Highlights section of the Prescribing Information for Arnuity Ellipta. Please consult the full Prescribing Information for all the labeled safety information for Arnuity Ellipta.
Arnuity Ellipta is contraindicated for primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any ingredients of Arnuity Ellipta.
Candida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta. Patients should rinse their mouth with water without swallowing after inhalation.
Do not use Arnuity Ellipta for relief of acute symptoms.
Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.
Risk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Arnuity Ellipta....
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