GSK新复方药Relvar Ellipta获欧盟批准

葛兰素史克（GSK）与Theravance公司11月18日宣布，新复方药物Relvar Ellipta（fluticasone furoate/vilanterol，FF/VI）已获欧盟委员会（EC）批准，作为首个每日一次的吸入性疗法，用于哮喘（asthma ）和慢性阻塞性肺病（COPD）的治疗。其中，FF/FV（2种规格：92/25 mcg，184/22mcg）适用于哮喘的治疗，FF/FV（92/25 mcg）适用于COPD的治疗。

Relvar Ellipta的批准，适用于欧洲31个国家，获批的适应症包括：12岁及以上青少年和成人哮喘（asthma）患者的常规治疗（regular treatment），既往有COPD病情加重(COPD exacerbation)病史的慢性阻塞性肺病患者的对症治疗（symptomatic treatment）。

Relvar Ellipta是实验性新复方药物FF/VI（fluticasone furoate /vilanterol）的拟用商品名，采用新型干粉吸入器（DPI）Ellipta给药，该药为每日1次的吸入型糖皮质激素（ICS）糠酸氟替卡松(FF)和长效β2受体激动剂（LABA）维兰特罗(VI)的复方药物，旨在开发用于慢性阻塞性肺病（COPD）和哮喘（asthma）的治疗。

今年5月，FF/VI获FDA批准，商品名为Breo Ellipta，作为每日一次的吸入性疗法，用于慢性阻塞性肺病（COPD）患者的长期维持治疗，包括慢性支气管炎和/或肺气肿。此外，该药还适用于既往有COPD病情加重(COPD exacerbation)病史患者的COPD病情加重的减少。

今年9月，FF/VI获日本劳动卫生福利部（MHLW）批准，作为首个每日一次的吸入性疗法，用于12岁及以上青少年及成人哮喘（asthma）的常规治疗，但不适用于慢性阻塞性肺病（COPD）的治疗。

在欧洲，FF/VI的规格（92/22 mcg，184/22 mcg）均指定为递送剂量（从吸入器射出），低强度（92/22mcg）规格相当于100/25mcg规格的预分注剂量（包含在吸入器内），高强度（184/22 mcg）相当于200/25mcg规格的分注剂量。

英文原文：RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD

Issued: Monday 18 November 2013, London, UK & South San Francisco, CA – LSE announcement

GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) announced today that the European Commission has granted marketing authorisation for RELVAR® ELLIPTA®, which is now licensed across 31 European countries for the following uses:

Asthma: the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists.

COPD: the symptomatic treatment of adults with chronic obstructive pulmonary disease (COPD) with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.

Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2-agonist (LABA), vilanterol “VI” (FF/VI). Two strengths of FF/VI have been licensed for the treatment of asthma (92/22 mcg and 184/22 mcg) and one strength has been licensed for the treatment of COPD (92/22 mcg). Both strengths will be administered once-daily using Ellipta, a new dry powder inhaler (DPI).

Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment to GSK of $15 million (USD) following marketing authorisation for Relvar Ellipta from the European Commission.  A further $15 million (USD) payment to GSK will follow the launch of Relvar Ellipta in Europe.

As part of its assessment, the European Medicines Agency reviewed results of 10 clinical studies in 7,783 patients with COPD and 16 studies in 9,326 patients with asthma.

In Europe, the FF/VI strengths of 92/22 mcg and 184/22 mcg are specified as the delivered doses (emitted from the inhaler). The lower strength is equivalent to the 100/25 mcg pre-dispensed dose (contained inside the inhaler) and the higher strength is equivalent to the 200/25 mcg pre-dispensed dose.