FDA批准Breo Ellipta用于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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FDA approves Breo Ellipta to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
COPD is a serious lung disease that worsens over time. Symptoms can include chest tightness, chronic cough and excessive phlegm. Cigarette smoking is the leading cause of COPD, according to the National Heart, Lung, and Blood Institute, and COPD is the third leading cause of death in the United States.
Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD.
“COPD is a serious disease that makes breathing difficult,” said Curtis Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, FDA. “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”
Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). The safety and efficacy of Breo Ellipta were evaluated in 7,700 patients with a clinical diagnosis of COPD. Those treated showed improved lung function and reduced exacerbations compared to placebo.
The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma.
The FDA approved Breo Ellipta with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug. Breo Ellipta should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.
Breo Ellipta may cause serious side effects, including increased risks of pneumonia and bone fractures. The most common side effects reported by patients using Breo Ellipta included inflammation of the nasal passage (nasopharyngitis), upper respiratory tract infection, headache, and oral candidiasis (thrush).
Breo Ellipta was developed by GlaxoSmithKline, Research Triangle Park, N.C., in collaboration with San Francisco-based Theravance.