5月10日，美国食品药品管理局（FDA）批准Breo Ellipta用于包括慢性支气管炎和/或肺气肿在内的慢性阻塞性肺病（COPD）患者气流阻塞的长期维持治疗，该药物为糠酸氟替卡松和维兰特罗的吸入型复方药物粉末，可每日吸入一次。Breo Ellipta还被批准用于减少患者的慢性阻塞性肺病发作。

慢性阻塞性肺病是一种严重的肺疾病，可随时间的推移而恶化。症状有胸闷、久咳和过度痰液。根据美国国家心脏、肺和血液研究所提供的信息，吸烟是慢性阻塞性肺病的主要因素，而慢性阻塞性肺病在美国是第三大主要死亡原因。Breo Ellipta可通过减轻慢性阻塞性肺病患者肺部的炎症，以及松弛肺气道周围的肌肉来增加气流及减少疾病的发作。

FDA药品评价与研究中心药物评价II办公室的主任Curtis Rosebraugh医学博士说：“慢性阻塞性肺病是一种造成呼吸困难的严重疾病，新型的长期维持药物的应用为美国数百万遭受该病困扰的患者提供了一种新的治疗选择。”

Breo Ellipta中的糠酸氟替卡松是一种吸入型糖皮质激素，维兰特罗是一种长效β2肾上腺素受体激动剂（LABA）。该药物的安全性和有效性通过一项7700名慢性阻塞性肺病患者参与的临床试验进行了评价。用药组患者相比安慰剂组患者其肺部功能得到了改善，疾病发作次数减少。

Breo Ellipta在获批时其标签内容中有一项黑框警告，提示长效β2肾上腺素受体激动剂能增加哮喘有关的死亡风险。这款药物对哮喘患者的安全性和有效性还没得到确认，所以没被批准用于哮喘的治疗。

FDA在批准Breo Ellipta时附带一患者用药指南，内容包含该药物的使用说明和用药后的潜在风险信息。Breo Ellipta不能作为一种急救措施用于治疗突然的呼吸困难（急性支气管痉挛），也不建议用于18岁以下患者。

Breo Ellipta可能会引起严重的副作用，包括肺炎和骨折的风险增加。Breo Ellipta用药患者报道的最常见副作用有鼻腔炎症（鼻咽炎）、上呼吸道感染、头痛及口腔念珠菌病（鹅口疮）。

Breo Ellipta由葛兰素史克与总部位于旧金山的治疗先锋公司联合开发。

Breo Ellipta (vilanterol/fluticasone) matches Advair in RCT (Chest)
Breo Ellipta (GlaxoSmithKline) is the first FDA-approved combination product with a once-daily long acting beta agonist (vilanterol) and inhaled corticosteroid (fluticasone). Additional once daily combination ICS/LABA and LABA/antimuscarinics are expected to launch over the next decade, increasing the options for treatment of asthma and COPD.

GSK got good news in the October Chest, with the publication of a study showing Breo Ellipta (once daily fluticasone/vilanterol) measured up well in a randomized trial against Advair (twice-daily fluticasone/salmeterol) for adults and adolescents with persistent asthma.

Ashley Woodcock et al randomized 806 patients with asthma (FEV1 40-80% predicted, with bronchodilator response) to receive either q.h.s. vilanterol/fluticasone or b.i.d. salmeterol/fluticasone, while also using a placebo dummy version of the other inhaler.

After 6 months, both groups had equivalent improvements in FEV1 (+341 mL for Breo Ellipta and +377 mL for Advair), quality of life questionnaire scores, and asthma control scores. There were no differences in asthma exacerbation rates and no adverse events attributed to either inhaler.

Breo Ellipta is at this writing only FDA-approved for the treatment of COPD. (European regulators recommended its approval there as an asthma treatment, as well.) Adding an asthma indication in the U.S. would vastly increase Breo Ellipta’s market potential for GSK. About 12 million U.S. adults have COPD, but 25 million are estimated to have asthma.

The once-daily products coming into the marketplace should make medication adherence easier for patients, but will also sell at premium brand prices just as established drugs like Advair (which sold almost $8 billion a year at its peak) are coming off patent. The FDA has signaled it will set a low bar for generic copies of Advair to gain regulatory approval