GlaxoSmithKline plc today announced that the Food and Drug Administration has approved Arnuity™ Ellipta® (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm.
The approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.
Darrell Baker, Senior Vice President & Head, GSK Global Respiratory Franchise, said, "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients."
The efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma.
Full US Prescribing Information, including Patient Information Leaflet, will be available soon at:us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts.
Arnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.
Asthma is a chronic lung disease that inflames and narrows the airways.1 Approximately 26 million people in the USA currently have asthma.2 Despite medical advances, more than half of patients continue to experience poor control and significant symptoms.3
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.
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 may 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.
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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. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.
- Global Initiative for Asthma. Pocket Guide for asthma management and prevention. Updated 2014.
- American Lung Association, Epidemiology and Statitics Unit, Research and Program Services Division,Trends in Asthma Morbidity and Mortality, September 2012, www.lungusa.org/finding-cures/our-research/trend-reports/asthma-trend-report.pdf
- Demoly et al. Eur Respir Rev. 2012 Mar 1;21(123):66-74. doi: 10.1183/09059180.00008111.