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.
","publishDateTime":"20/08/2014 00:00:00","publishDate":"20 August 2014","forInvestorsAndMediaOnlyText":"","shortDescription":"GSK announced that the FDA has approved Arnuity™ Ellipta® for treatment of asthma in patients aged 12 years and older.","image":null,"downloadLink":null,"tags":[]},"components":[{"type":"rich-text","text":"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.
\nThe 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.
\nDarrell 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.”
\nThe efficacy and safety of Arnuity Ellipta have been evaluated in more than 3,600 patients with asthma.
\nFull 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.
\nArnuity and Ellipta are trademarks of the GlaxoSmithKline group of companies.
\nAsthma 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
\nThe 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.
\nThe 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.
\nArnuity 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.
\nCandida albicans infection of the mouth and throat may occur in patients treated with Arnuity Ellipta.
\nDo not use Arnuity Ellipta for relief of acute symptoms.
\nPatients 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.
\nRisk of impaired adrenal function when transferring from systemic corticosteroids. Wean patients slowly from systemic corticosteroids if transferring to Arnuity Ellipta.
\nHypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals.
\nDiscontinue Arnuity Ellipta and institute alternative therapy if paradoxical bronchospasm occurs.
\nMonitor patients with major risk factors for decreased bone mineral content.
\nMonitor growth of adolescent patients.
\nClose monitoring for glaucoma and cataracts is warranted.
\nThe 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.
\nUse Arnuity Ellipta with caution in patients taking strong cytochrome P450 3A4 inhibitors (eg ketoconazole) because this may cause systemic corticosteroid effects.
\nFluticasone furoate exposure may increase in patients with moderate or severe hepatic impairment. Monitor for systemic corticosteroid effects.
\nGSK – 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.
\nGSK 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.
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