GSK, Theravance submit MAA for COPD product

GlaxoSmithKline plc (LSE:GSK, NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) said they submitted an MAA to EMA for Anoro umeclidinium bromide/vilanterol for maintenance bronchodilator treatment in adults 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) administered with the Ellipta inhaler. In December, GSK submitted an NDA to FDA for Anoro. The pharma said it also plans to start global regulatory submissions of umeclidinium bromide as a monotherapy later this year. ...