FDA to discuss Anoro Ellipta for COPD

FDA's Pulmonary-Allergy Drugs Advisory Committee will meet on Sept. 10 to discuss an NDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Anoro Ellipta umeclidinium bromide/vilanterol for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The product is a fixed-dose inhaled dry powder formulation of umeclidinium bromide, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA). The PDUFA date is Dec. 18. Anoro Ellipta is also under review in Japan and Europe. ...