GSK submits MAA for umeclidinium bromide monotherapy

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) submitted an MAA to EMA for umeclidinium bromide as monotherapy for maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstruction pulmonary disease (COPD). The pharma said a U.S. submission for the long-acting muscarinic antagonist (LAMA) administered with the Ellipta inhaler is "imminent."

A fixed-dose inhaled dry powder formulation combination of umeclidinium bromide and vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA), is already under review under the name Anoro Ellipta in Japan, Europe and the U.S., where it has a Dec. 18 PDUFA date. GSK and Theravance Inc. (NASDAQ:THRX) are partnered under a 2002 deal to develop compounds to treat asthma and COPD that covers the fixed-dose combination but not the monotherapy. ...