CHMP backs two COPD products
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) said EMA's CHMP recommended approval of an MAA from GSK for Anoro Ellipta umeclidinium bromide/vilanterol as a once-daily maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). The product is already approved in Canada and the U.S., where a launch is expected this quarter. Separately, GSK said CHMP backed approval of umeclidinium bromide as monotherapy for the indication under the name Incruse. An NDA for umeclidinium bromide monotherapy is under FDA review, with an April 30 PDUFA date.
Umeclidinium bromide is a long-acting muscarinic antagonist (LAMA). Anoro Ellipta is a fixed-dose, inhaled dry powder formulation of umeclidinium bromide and vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA). GSK and Theravance are partnered under a 2002 deal to develop compounds to treat asthma and COPD. The deal covers the fixed-dose combination of umeclidinium bromide/vilanterol but not umeclidinium bromide monotherapy. ...