FDA批准umeclidinium用于每日1次COPD维持治疗

葛兰素史克（GSK）4月30日宣布，美国食品药品管理局（FDA）已批准umeclidinium作为气流阻塞的慢性阻塞性肺病（COPD）患者每日1次的长期治疗用药。

IncruseEllipta （umeclidinium）为长效毒蕈碱拮抗剂，含有62.5 μg umeclidinium，通过Ellipta吸入器给药。

据美国国家心肺血液研究所（NHLBI），COPD是一种包括慢性支气管炎、肺气肿或兼有两种疾病的肺部疾病，累及约270万美国人。

Umeclidinium III期临床试验包括7项临床试验，共纳入随机接受umeclidinium或安慰剂治疗的 2,500余例COPD患者。

接受IncruseEllipta和安慰剂治疗的患者常见不良事件为鼻咽炎（8% vs. 7%)、上呼吸道感染（5% vs. 4%)、咳嗽（3% vs. 2%)以及关节痛（2% vs. 1%)。不推荐该药物用于快速恶化或可能危及生命的COPD发作治疗，也不推荐作为支气管痉挛急性发作抢救治疗。

还建议该药物慎用于闭角青光眼患者和尿潴留患者，特别是前列腺增生或膀胱颈梗阻患者。

IncruseEllipta目前已获准在加拿大和欧洲上市，在其他多个国家也正在接受审评。GSK称，预计该药物于2014年4季度在美国上市。

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By:  REBECCA KERN, Frontline Medical News 

The Food and Drug Administration has approved umeclidinium as a once-daily, long-term treatment for airflow obstruction for patients with chronic obstructive pulmonary disease, GlaxoSmithKline announced April 30.

IncruseEllipta (umeclidinium) is a long-acting muscarinic antagonist. It includes 62.5 mcg of umeclidinium delivered with the Ellipta inhaler.

Approximately 27 million people in the United States are affected by COPD, a lung disease that includes chronic bronchitis, emphysema, or both, according to the National Heart, Lung, and Blood Institute.

The phase III clinical trial for umeclidinium included seven clinical trials, which enrolled more than 2,500 COPD patients randomized to umeclidinium or placebo.

The most common adverse events with IncruseEllipta (and placebo) were nasopharyngitis, 8% (7%); upper respiratory tract infection, 5% (4%); cough, 3% (2%); and arthralgia, 2% (1%). The drug is not recommended during rapidly deteriorating or potentially life-threatening COPD episodes, or as a rescue therapy for acute episodes of bronchospasm.

It is also recommended for the drug to be used with caution in patients with narrow-angle glaucoma and patients with urinary retention, especially prostatic hyperplasia or bladder neck obstruction.

IncruseEllipta is currently approved in Canada and Europe, and is under review in several other countries. The firm says it plans to launch the drug in the United States in the fourth quarter of 2014.