GSK Submits Regulatory Application in Japan for Once-Daily Single Inhaler Triple Therapy FF/UMEC/VI for Patients with COPD

GlaxoSmithKline (LSE/NYSE: GSK) and Innoviva (NASDAQ: INVA) today 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).

As quoted in the press release:

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 exacerbations 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.”¹

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.

Click here to read the full press release.