一年连中四元——葛兰素史克哮喘新药Arnuity Ellipta获FDA批准

近一年来，葛兰素史克（GSK）呼吸管线可谓收获颇丰，接连有4种新药获得FDA批准。同时，GSK正在开发COPD三联疗法（FF/UMEC/VI），意在进一步扩大其在呼吸疾病领域的领先优势。

葛兰素史克（GSK）8月20日宣布，FDA已批准Arnuity Ellipta（糠酸氟替卡松吸入粉剂），作为一种预防性疗法（prophylactic therapy），用于12岁及以上哮喘患者的维持治疗。Arnuity为每日一次的吸入性糖皮质激素（ICS）药物，不适用于急性支气管痉挛的缓解。

Arnuity Ellipta是一种糠酸氟替卡松（fluticasone furoate，FF）单药疗法，获批剂量为100mcg和200mcg，该药通过干粉吸入器Ellipta给药，其疗效和安全性已在大型临床项目中得到验证，涉及超过3600例哮喘患者。Ellipta干粉吸入器已广泛用于一系列其他已获批的呼吸药物。

Arnuity Ellipta的获批，也标志着葛兰素史克呼吸管线在一年多点时间内获FDA批准的第4个产品。其他3种产品分别为：Incruse Ellipta（umeclidinium，UMEC），该药为首个长效毒蕈碱受体拮抗剂（LAMA）单药疗法，用于慢性阻塞性肺病（COPD）的治疗；Breo Ellipta（fluticasone furoate/vilanterol，FF/VI），该药为每日1次的吸入型糖皮质激素糠酸氟替卡松(FF)和长效β2受体激动剂维兰特罗(VI)的复方药物，用于慢性阻塞性肺病（COPD）和哮喘的治疗；Anoro Ellipta（umeclidinium/vilanterol，UMEC/VI），该药为长效毒蕈碱受体拮抗剂（LAMA）UMEC（umeclidinium）和长效β2受体激动剂维兰特罗(VI，vilanterol)的复方药物，是GSK的一个独特产品，是获FDA批准的首个LAMA/LABA组合药物。

目前，葛兰素史克已计划扩大其在呼吸疾病领域的领先优势，与长期合作伙伴Theravance公司启动了COPD三联疗法（FF/UMEC/VI）的III期临床项目，该三联疗法（FF/UMEC/VI）是一种ICS/LAMA/LABA组合疗法，组成为：FF（Fluticasone furoate，糠酸氟替卡松，一种吸入性皮质类固醇，ICS）+UMEC（umeclidinium，一种长效毒蕈碱拮抗剂，LAMA）+VI（vilanterol，维兰特罗，一种长效β2受体激动剂，LABA）。该项目首个III期IMPACT将招募约1万例COPD患者，将调查三联疗法是否能降低COPD中度和重度发作（exacerbation）的年发作率。（生物谷Bioon.com）

英文原文：GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the USA for the treatment of asthma

20 August 2014

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.

About asthma
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.