葛兰素史克COPD新药Incruse Ellipta获FDA批准

关键词:葛兰素史克,慢性阻塞性肺病,COPD,Incruse Ellipta,umeclidinium

2014年5月2日讯 /生物谷BIOON/ --葛兰素史克(GSK)4月30日宣布,药物Incruse Ellipta(umeclidinium)获FDA批准,作为一种长期的、每日一次的维持性支气管扩张药物,用于治疗慢性阻塞性肺病(COPD)(包括慢性支气管炎和肺气肿)患者的气流阻塞(airflow obstruction)。GSK预计在2014年第四季度在美国推出该药。

Incruse Ellipta是葛兰素史克首个长效毒蕈碱受体拮抗剂(LAMA)单药疗法,FDA批准的剂量为62.5微克,该药采用新型干粉吸入器Ellipta给药。umeclidinium是一类支气管扩张剂,是一种长效毒蕈碱拮抗剂(LAMA),又名长效抗胆碱能药物,能够影响呼吸道周围的肌肉,阻止肌肉收缩。

Umeclidinium的临床项目包括7项III期临床试验,涉及超过2500例COPD患者。

今年4月18日,Incruse Ellipta获加拿大批准,作为一种长期的、每日一次的维持性支气管扩张药物,用于治疗慢性阻塞性肺病(COPD)(包括慢性支气管炎和肺气肿)患者的气流阻塞(airflow obstruction),该药不适用于COPD急性恶化的缓解,并且不应用于18岁以下患者。这是Incruse Ellipta在全球范围内获得的首个监管批准,

今年4月28日,Incruse Ellipta获欧盟委员会(EC)批准,作为每日一次的维持性支气管扩张剂,用于慢性阻塞性肺病(COPD)成人患者,缓解疾病症状。目前,该公司正期待着推进其他国家和地区的监管申请。(生物谷Bioon.com)

英文原文:GSK receives approval for Incruse™ Ellipta® (umeclidinium) in the US for the treatment of COPD

Issued: Wednesday 30 April 2014, London UK – LSE announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Incruse™ Ellipta® (umeclidinium) as an anticholinergic indicated 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.

Umeclidinium is GSK’s first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA), and is contained in the Ellipta® inhaler. The FDA-approved strength is 62.5 mcg.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “We believe Incruse Ellipta, our first monotherapy in the anticholinergic class, will be an important once-daily treatment option for appropriate patients with COPD. GSK has a long-standing commitment to the development of respiratory medicines in order to offer physicians a choice of treatment options for their patients. We are delighted by this approval, and are looking forward to making Incruse Ellipta available for appropriate patients with COPD in the US.”

Following this approval by the FDA, it is anticipated that launch activities in the US will commence during the fourth quarter of 2014.

The phase III pivotal programme for umeclidinium included seven clinical studies which involved over 2,500 COPD patients treated with umeclidinium or placebo.

About COPD

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both.  COPD is characterised by obstruction to airflow that interferes with normal breathing. The National Heart, Lung and Blood Institute (NHLBI) estimates that nearly 27 million people in the US alone are affected by COPD.[i]

According to the NHLBI, long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. In the United States, the most common irritant that causes COPD is cigarette smoke.  Breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace also can contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.

About Incruse Ellipta

Incruse Ellipta is an anticholinergic approved in the US 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. Incruse contains 62.5 mcg umeclidinium delivered by the Ellipta inhaler.

Full US Prescribing Information including Patient Information Leaflet will be available soon at: us.gsk.com. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the “GSK Inquiries” section at the end of this document.

(责任编辑:lishuheng)

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