GSK, Theravance submit Japanese NDA for COPD product
Theravance Inc. (NASDAQ:THRX) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said GSK submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Anoro Ellipta umeclidinium bromide/vilanterol for bronchodilator maintenance treatment of airflow obstruction in patients with chronic obstruction pulmonary disease (COPD). The product is already under review in Europe and in the U.S., where it has a Dec. 18 PDUFA date. Anoro Ellipta 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. GSK also plans to submit global regulatory applications this year for umeclidinium bromide as monotherapy administered using the Ellipta inhaler to treat COPD. ...