Current Edition

GSK Applies in Japan for Approval of a Once-Daily, Single Inhaler Triple Therapy for COPD

First filing made for a triple therapy for chronic obstructive pulmonary disease offered in a single inhaler.

Chronic obstructive pulmonary disease (COPD) affects over five million people in Japan, many of whom require treatment with different medications to reduce all of their symptoms. At this point, however, there is no single inhaler available that includes a combination of the common drugs used to treat COPD.
GlaxoSmithKline is hoping to change that. The company has submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for the treatment of adults with COPD.
The proposed brand name is Trelegy Ellipta, and the proposed indication is for the relief of various symptoms with COPD (chronic bronchitis, pulmonary emphysema) for patients that require concurrent use of an inhaled corticosteroid, a long-acting inhaled beta2-agonist and a long-acting inhaled anticholinergic.
The New Drug Application is based on the results of a Phase III IMPACT clinical trial involving 378 patients from Japan. The triple therapy in a single inhaler was shown to provide better results compared to a combination of inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) (Relvar/Breo Ellipta (FF/VI)) and a combination of long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA) (Anoro Ellipta (UMEC/VI)) for several clinically important endpoints.