GSK drops COPD indication from Relvar Ellipta Japanese NDA

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) withdrew chronic obstructive pulmonary disease (COPD) as an indication on the Japanese NDA for Relvar Ellipta fluticasone furoate/vilanterol. The product -- a once-daily, fixed dose combination of the inhaled corticosteroid fluticasone furoate and a long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler -- is still under review for asthma, with a decision expected by year end.

GSK and partner Theravance Inc. (NASDAQ:THRX) said two six-month trials in Japanese patients "demonstrated the benefit of the combination" of Relvar Ellipta vs. placebo on the co-primary endpoints of weighted mean and trough forced expiratory volume in 1 second (FEV1). However, the partners said an assessment of data from the trials showed the vilanterol component alone significantly improved a co-primary endpoint while the fluticasone furoate component alone did not. As a result, GSK said it believes the six-month data alone "may be insufficient to support the efficacy of the combination and its components in this specific patient group." The partners did not enroll Japanese patients in 52-week exacerbation trials of Relvar Ellipta. ...