GSK submits US regulatory filing of Arnuity Ellipta in children with asthma
24 July 2017
Issued: London UK
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced the filing of a supplementary New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years (inclusive). The sNDA is seeking approval for a dose of 50mcg once-daily, delivered using the Ellipta inhaler in this group of patients.
Arnuity Ellipta (fluticasone furoate 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.
Today’s submission includes data from a pivotal study assessing the efficacy and safety of once daily fluticasone furoate, compared to placebo, in 593 children aged 5 to 11 years (inclusive) with asthma. The primary endpoint of the 12-week study was the mean change from baseline in daily morning peak expiratory flow (PEF).1
Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment.
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). None of the doses studied are currently approved for use in children aged 5 to 11 years.
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.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.
Discontinue Arnuity Ellipta and institute alternative therapy if paradoxical bronchospasm occurs.
Monitor patients with major risk factors for decreased bone mineral content.
Monitor growth of adolescent patients.
Close monitoring for glaucoma and cataracts is warranted.
The most common adverse reactions (reported in greater than or equal to 5% of subjects) with Arnuity Ellipta were upper respiratory tract infection, nasopharyngitis, headache, and bronchitis.
Use Arnuity Ellipta with caution in patients taking strong cytochrome P450 3A4 inhibitors (eg ketoconazole) because this may cause systemic corticosteroid effects.
Fluticasone furoate exposure may increase in patients with moderate or severe hepatic impairment. Monitor for systemic corticosteroid effects.
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
ARNUITY and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.
- J Pediatr 2016;178:246-53. Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma Trial registration ClinicalTrials.gov: NCT01563029.
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2016.