FDA批准复方药Breo Ellipta用于治疗COPD

圣路易斯(MD Consult)——2013年5月10日，美国食品药品管理局(FDA0)和葛兰素史克公司宣布Breo Ellipta(糠酸氟替卡松/维兰特罗吸入性粉剂)获准用作慢性阻塞性肺病(COPD)患者气流阻塞的维持治疗，包括慢性支气管炎和(或)肺气肿。对于有加重病史的患者，该药还适用于减少其COPD加重的发作次数。Breo Ellipta用于哮喘患者的安全性和有效性尚未得到证实，故未获准用于哮喘患者。

Breo Ellipta的安全性和有效性评估涉及7,700例临床诊断为COPD的患者。研究结果显示，与安慰剂相比，接受该药治疗的患者肺功能改善，加重的发作次数减少。

在2项为期6个月的Breo Ellipta(与安慰剂对比)临床试验中报告最多的不良反应是鼻咽炎、上呼吸道感染、头痛及口腔念珠菌病。除了这2项试验中报告的不良事件外，在另外2项为期1年的研究中，一些患者在接受Breo Ellipta治疗期间还会出现COPD、背痛、肺炎、支气管炎、鼻窦炎、咳嗽、口咽痛、关节痛、高血压、流感、咽炎、腹泻、周围水肿及发热等不良事件。

该药物的标签中有一个黑框警告，内容为长效β2激动剂(LABAs)(如维兰特罗)可增加哮喘相关死亡的风险。Breo Ellipta不宜在COPD快速恶化或发生潜在致死性发作期间开始用药，也不宜作为支气管痉挛急性发作的抢救治疗药。使用Breo Ellipta可能发生的严重不良事件包括肺炎和骨折。

Breo Ellipta是一种每日1次用药的长期吸入性药品，预计于2013年第3季度上市。

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ST LOUIS (MD Consult) - On May 10, 2013, the US Food and Drug Administration (FDA) and GlaxoSmithKline announced the approval of Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) as maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and the drug is not approved for use in patients with asthma.

The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD. Patients treated with the product showed improved lung function and reduced exacerbations compared with placebo.

The most common adverse reactions reported in two 6-month clinical trials with Breo Ellipta (and placebo) were nasopharyngitis, upper respiratory tract infection, headache, and oral candidiasis. In addition to events reported in the 6-month studies, adverse reactions that occurred in some patients treated with Breo Ellipta in two 1-year studies included COPD, back pain, pneumonia, bronchitis, sinusitis, cough, oropharyngeal pain, arthralgia, hypertension, influenza, pharyngitis, diarrhea, peripheral edema, and pyrexia.

The drug label carries a Boxed Warning that long-acting beta2 agonists (LABAs) (eg, vilanterol) increase the risk of asthma-related death. Breo Ellipta should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD, nor as rescue therapy for the treatment of acute episodes of bronchospasm. Serious adverse events that may occur with use of Breo Ellipta include pneumonia and bone fractures.

Breo Ellipta is a long-term, once daily, inhalation product. It is anticipated that it will be available in the third quarter of 2013.