GlaxoSmithKline has received Canadian marketing authorisation for its Incruse Ellipta (umeclidinium, as umeclidinium bromide), 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.
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.
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.