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葛兰素史克COPD新药Incruse Ellipta获欧盟批准

2014年4月28日讯 /生物谷BIOON/ --葛兰素史克(GSK)4月28日宣布,Incruse Ellipta(umeclidinium)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。GSK预计将在2014年年底在欧洲推出该药。

此次批准,适用于所有欧盟成员国。Incruse为每日一次的长效毒蕈碱拮抗剂(LAMA),这是一种支气管扩张,又名长效抗胆碱能药物

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,含有55微克剂量吸入性干粉,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。

欧洲药品管理局(EMA)审查了umeclidinium临床项目后对该药进行了评估。该项目包括7项III期临床试验,涉及超过2500例COPD患者。其中,576例患者接受了推荐剂量的umeclidinium(55毫克,每日一次)治疗。

今年4月18日,Incruse Ellipta(umeclidinium)获得了加拿大批准,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,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 EU marketing authorisation for Incruse (umeclidinium) for the treatment of COPD

Issued: Monday 28 April 2014, London UK – LSE Announcement

GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the European Commission has granted marketing authorisation for Incruse® (umeclidinium) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Now licensed across all EU member states, Incruse is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic. Incruse is a 55mcg strength inhalation powder delivered by the Ellipta® inhaler.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, “COPD affects millions of people in Europe and for many years we have been committed to researching and improving understanding of it. We are delighted by today’s marketing authorisation for Incruse Ellipta, our first LAMA, which will provide healthcare professionals with a further treatment option for appropriate COPD patients. This is in line with our goal to develop a range of respiratory medicines that allow physicians to make treatment choices based on their individual patients’ needs.”

It is expected that the first launches will have taken place in Europe by the end of 2014.

The EMA assessment of umeclidinium included a review of seven phase III clinical trials which included over 2,500 COPD patients treated with umeclidinium or placebo. Within this, 576 patients received the recommended dose of umeclidinium 55mcg once-daily.

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. COPD is thought to affect 4-10% of the adult population in Europe.[i]

Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin.[ii]

Other Umeclidinium Regulatory Activity:

In April 2014, umeclidinium was licensed in Canada under the brand name Incruse Ellipta for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

In April 2013, a New Drug Application (NDA) for umeclidinium monotherapy (62.5mcg) was submitted to the US Food and Drug Administration (FDA) and is currently under review. The proposed umeclidinium dose of 62.5mcg is specified as the pre-dispensed dose (contained inside the inhaler) which is equivalent to the 55mcg delivered dose (emitted from the inhaler) authorised in Europe.

Regulatory applications for umeclidinium have been submitted and are undergoing assessment in a number of other countries. Umeclidinium is not licensed anywhere outside of the EU and Canada.

Incruse® and Ellipta® are trademarks of the GSK group of companies.

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

信息来源:生物谷