FDA Advisory Committee recommends Anoro Ellipta for COPD

GlaxoSmithKline plc and Theravance, Inc. announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the FDA voted 11 yes to 2 no that the 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.

Anoro Ellipta is the proposed proprietary name for UMEC/VI, a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), 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).

The FSA committee have called for a post-marketing study in patients with more severe cardiovascular disease.

A final decision from the FDA is expected by 18 December 2013 .