FDA Panel Votes In Favor Of Glaxo-Theravance's Lung Drug

(RTTNews) - GlaxoSmithKline plc. (GSK, GSK.L) and Theravance Inc. (THRX) announced that the Pulmonary-Allergy Drugs Advisory Committee or PADAC to the US Food and Drug Administration or 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 or 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 or UMEC, a long-acting muscarinic antagonist or LAMA and vilanterol or VI, a long-acting beta2 agonist (LABA), administered using the ELLIPTA inhaler.

The companies said that 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 FDA Advisory Committee provides non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. The Prescription Drug User Fee Act or PDUFA goal date for UMEC/VI is 18 December 2013.