GlaxoSmithKline plc and Innoviva, Inc announced the submission of 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) under the proposed brand name of Trelegy Ellipta for the treatment of adults with chronic obstructive pulmonary disease (COPD). This is the first regulatory filing to be made in Japan for a triple COPD therapy in a single inhaler.

Dave Allen, head, respiratory therapy area R&D, GSK said: “COPD is a debilitating lung disease affecting over five million people in Japan. Many patients require combination treatment with different types of medicines to reduce both symptoms and exacerbation but there is currently no triple therapy available in Japan delivered in a single inhaler. If approved, once-daily FF/UMEC/VI delivered in the Ellipta would be an important innovation in the management of COPD in Japan alongside our current range of treatments.”

The New Drug Application is primarily based on data from the phase III IMPACT study which included 378 patients from Japan. In the overall study population, FF/UMEC/VI was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo Ellipta (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro Ellipta (UMEC/VI), on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life. Similar trends were observed in the Japanese population for the primary endpoint as well as across multiple secondary and supportive efficacy endpoints.

Dr Ted Witek, senior vice president and chief scientific officer at Innoviva added, “We are delighted to have filed a new drug application for the first single inhaler triple therapy for the treatment of COPD in Japan where the prevalence of COPD is of public concern. We look forward to a decision from the MHLW, which, if positive, would provide a new therapeutic option for appropriate patients with COPD in Japan.”

The proposed indication is for the relief of various symptoms with COPD (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of inhaled corticosteroid, long-acting inhaled beta2-agonist and long-acting inhaled anticholinergic drug is required.)

FF/UMEC/VI is currently licensed for use in the US, EU and a number of other countries under the brand name Trelegy Ellipta. It contains three molecules, an ICS, a LAMA and a LABA, delivered in the Ellipta dry powder inhaler which is used across GSK’s new portfolio of inhaled COPD medicines.

The landmark 10,355-patient InforMing the PAthway of COPD Treatment (IMPACT) study is the first study to directly compare three commonly-used COPD combination treatment classes delivered using the same dose and inhaler. It is the second of two Phase III studies designed to investigate the efficacy and safety of FF/UMEC/VI in a single inhaler compared to other commonly-used COPD combination treatments.

IMPACT evaluated as its primary endpoint the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) compared with FF/VI (100/25mcg) and UMEC/VI (62.5/25mcg), two once-daily dual COPD therapies from GSK’s existing portfolio. Results from IMPACT were recently published in the New England Journal of Medicine.

FF/UMEC/VI is the first COPD treatment to provide a combination of three molecules in a single inhaler that is taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler, which is used across GSK’s new portfolio of inhaled COPD medicines. FF/UMEC/VI is approved in the US for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma.

Regulatory applications for once-daily single inhaler triple therapy FF/UMEC/VI have been submitted and are undergoing assessment in a number of other countries worldwide.

GSK has led the way in developing innovative medicines to advance the management of asthma and COPD for nearly 50 years. Over the last five years we have launched six innovative medicines responding to continued unmet patient need, despite existing therapies. This is an industry-leading portfolio in breadth, depth and innovation, developed to reach the right patients, with the right treatment.