Canadian approval for GSK’s Incruse Ellipta as a treatment for COPD

UK pharma giant GlaxoSmithKline (LSE: GSK) says that Incruse Ellipta (umeclidinium) 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. However, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion recommending marketing authorization for Incruse for COPD (The Pharma Letter February 21). A New Drug Application for umeclidinium monotherapy is currently under review at the US Food and Drug Administration.

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 62.5mcg of umeclidinium delivered by GSK’s Elliptadry powder inhaler.