GSK, Theravance report COPD data for Incruse Ellipta/Relvar Ellipta

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Theravance Inc. (NASDAQ:THRX) said GSK's Incruse Ellipta umeclidinium bromide plus the partners' Relvar/ Breo Ellipta fluticasone furoate/vilanterol met the primary endpoint vs. placebo plus Relvar Ellipta in two Phase III trials to treat chronic obstructive pulmonary disease (COPD). In the Phase III 200110 trial, once-daily doses of 62.5 and 125 ug Incruse Ellipta plus Relvar Ellipta improved trough forced expiratory volume in one second (FEV1) from baseline to day 85 by 122 mL at the low dose and by 111 mL at the high dose compared to placebo plus Relvar Ellipta (p<0.001 for both). In the Phase III 200109 trial, Incruse Ellipta plus Relvar Ellipta improved trough FEV1 from baseline to day 85 by 124 mL at the low dose and by 128 mL at the high dose compared to placebo plus Relvar Ellipta (p<0.001 for both).

GSK's Incruse Ellipta is a long-acting muscarinic antagonist (LAMA) delivered via the Ellipta inhaler. The 62.5 ug dose is approved for COPD in the U.S., Europe and Canada; the 125 mg dose is not approved anywhere. GSK and Theravance market fluticasone furoate/vilanterol for COPD as Breo Ellipta in the U.S. and as Relvar Ellipta in Europe. The product -- a fixed-dose combination of an inhaled corticosteroid and a long-acting adrenergic receptor beta 2 agonist (LABA) -- is also approved for asthma in Japan. The companies could not be reached for next steps for a combination of Incruse Ellipta and Relvar Ellipta. ...