London, UK 21 May 2018 –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).
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.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Arnuity Ellipta slowly.
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 children and adolescent patients.
Close monitoring for glaucoma and cataracts is warranted.
The most common adverse reactions (reported in greater than or equal to 5% of adult and adolescent subjects) with Arnuity Ellipta were nasopharyngitis, bronchitis,upper respiratory tract infection, and headache.
Most common adverse reactions reported in ≥3% of paediatric subjects aged 5 to 11 years are pharyngitis, bronchitis, and viral infection.
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’s commitment to respiratory disease
GSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last four years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.
We remain at the cutting-edge of scientific research into respiratory medicine, working in collaboration with patients and the scientific community to offer innovative medicines aimed at helping to treat patients’ symptoms and reduce the risk of their disease worsening. While respiratory diseases are clinically distinct, there are important pathophysiological features that span them, and our ambition is to have the most comprehensive portfolio of medicines to address a diverse range of respiratory diseases. To achieve this, we are focusing on targeting the underlying disease-driving biological processes to develop medicines with applicability across multiple respiratory diseases. This approach requires extensive bioinformatics, data analytic capabilities, careful patient selection and stratification by phenotype in our clinical trials.
GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.
1. J Pediatr 2016;178:246-53. Randomized Trial of Once-Daily Fluticasone Furoate in Children with Inadequately Controlled Asthma Trial registration ClinicalTrials.gov: NCT01563029.
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 2017.
Posted: May 2018
Arnuity Ellipta (fluticasone furoate) FDA Approval History