葛兰素史克（GSK）4月17日宣布，Incruse Ellipta（umeclidinium）获加拿大卫生部批准，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。
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62.5微克umeclidinium，采用新型干粉吸入器Ellipta给药。umeclidinium是一类支气管扩张剂，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。
GSK announces approval in Canada for Incruse Ellipta (umeclidinium) as a treatment for COPD
Issued: Thursday 17 April 2014, London UK – LSE Announcement
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that Incruse™ Ellipta™ (umeclidinium, as umeclidinium bromide) has received market authorisation in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This is the first market authorisation granted for this product anywhere in the world.
Incruse Ellipta is GSK’s first long-acting muscarinic antagonist (LAMA) monotherapy, a type of bronchodilator also known as a long-acting anticholinergic. It contains 62.5 micrograms of umeclidinium delivered by GSK’s Ellipta dry powder inhaler.
Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “COPD affects a significant and growing number of people globally. For over 40 years GSK has been at the forefront of research and development of new respiratory medicines, and our goal in COPD is to introduce a range of medicines so that physicians can choose the treatment option which best meets their individual patients’ needs. We are delighted that our LAMA monotherapy has achieved its first approval, and are now looking forward to progressing the ongoing regulatory submissions elsewhere.”
The clinical programme for umeclidinium included seven phase III clinical trials which involved over 2,500 COPD patients treated with umeclidinium or placebo.
ab0ut COPD
Chronic obstructive pulmonary disease (COPD) is a term referring to two lung diseases, chronic bronchitis and emphysema, that are characterised by obstruction to airflow that interferes with normal breathing.
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.
ab0ut Incruse Ellipta
Incruse Ellipta is a new once-daily long-acting muscarinic antagonist (LAMA) approved in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. Incruse Ellipta is not indicated for the relief of acute deterioration of COPD, and should not be used in patients under 18 years of age. Incruse contains 62.5 micrograms umeclidinium delivered by the Ellipta inhaler.
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