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

September 11, 2013

An FDA Committee voted to support approval of GSK and Theravance?s umeclidinium/vilanterol for treatment of chronic pulmonary disease.

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).