GlaxoSmithKline plc announced that Incruse Ellipta (umeclidinium, as umeclidinium bromide) has received market authorization 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 authorization 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 and 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 program for umeclidinium included seven Phase 3 clinical trials which involved over 2,500 COPD patients treated with umeclidinium or placebo.
Date: April 17, 2014