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news.GlaxoSmithKline (GSK) has obtained marketing approval in Canada for its Incruse Ellipta (umeclidinium, as umeclidinium bromide), a new once-daily long-acting muscarinic antagonist (LAMA) approved 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.
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According to GSK, this is the first marketing approval granted for Incruse Ellipta 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. Incruse contains 62.5 micrograms umeclidinium that is delivered by GSK’s Ellipta dry powder inhaler.
GSK Global Respiratory Franchise senior vice president and head Darrell Baker noted that for over 40 years the company has been at the forefront of research and development of new respiratory medicines, and its 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," Baker added.
Umeclidinium has been evaluated in seven Phase III clinical trials, which enrolled 2,500 patients with COPD. These patients were treated with umeclidinium or placebo.
Incruse Ellipta is not indicated for the relief of acute deterioration of COPD. It should not be used in patients under 18 years of age.
Image: GlaxoSmithKline headquaters in London. Photo: Courtesy of Flickr upload bot