FDA Advisory Committee Recommends Approval for GSK and Theravance's COPD Drug

Sep 11, 2013
By PharmTech Editors

GlaxoSmithKline and Theravance announced that the Pulmonary–Allergy Drugs Advisory Committee (PADAC) to FDA voted 11-yes to 2-no that efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) 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, GSK announced in a press release.

ANORO ELLIPTA is the proposed proprietary name for UMEC/VI, which is a combination of two investigational bronchodilator molecules: umeclidinium bromide (UMEC), which is a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler. The FDA Advisory Committee also voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5/25mcg dose for the proposed indication (10-yes, 3-no), and the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD (13-yes, 0-no).