GSK: submits application for COPD in Japan
(CercleFinance.com) - GlaxoSmithKline (GSK) and Innoviva have announced submitting an application for authorisation for Trelegy Ellipta in the treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) to the Ministry of Health in Japan.
The UK health group specifies that this is the first regulatory application in Japan for a triple therapy (fluticasone furoate/umeclidinium/vilanterol once daily) for COPD in a single inhaler.
GSK explains that this request is primarily based on data from the Phase III Impact study of 378 patients in Japan, which demonstrated superiority in a number of primary endpoints.
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The UK health group specifies that this is the first regulatory application in Japan for a triple therapy (fluticasone furoate/umeclidinium/vilanterol once daily) for COPD in a single inhaler.
GSK explains that this request is primarily based on data from the Phase III Impact study of 378 patients in Japan, which demonstrated superiority in a number of primary endpoints.
Copyright (c) 2018 CercleFinance.com. All rights reserved.