GSK submits NDA for COPD product

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Theravance Inc. (NASDAQ:THRX) said GSK submitted an NDA to FDA for Anoro Ellipta umeclidinium bromide/vilanterol for maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The product is a fixed-dose inhaled dry powder formulation of a long-acting muscarinic antagonist (LAMA) and a long-acting adrenergic receptor beta 2 agonist (LABA). The partners they expect to submit a regulatory application in the EU "imminently," with additional worldwide submissions slated for next year. ...