ARTICLE | Clinical News

Incruse umeclidinium bromide regulatory update

February 24, 2014 8:00 AM UTC

GlaxoSmithKline said EMA's CHMP recommended approval of an MAA for umeclidinium bromide under the name Incruse as monotherapy for once-daily maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). An NDA for umeclidinium bromide monotherapy is under FDA review, with an April 30 PDUFA date. Separately, GSK and partner Theravance Inc. (NASDAQ:THRX, South San Francisco, Calif.) said CHMP backed approval of Anoro Ellipta umeclidinium bromide/vilanterol for the indication. CHMP also backed approval of the product under the name Laventair. The product is already approved in Canada and the U.S., where a launch is expected this quarter. The Canadian launch is slated for 2Q14. A decision from the European Commission on both products is expected next quarter.

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. ...