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，
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.
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.