GlaxoSmithKline and Innoviva have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the 100/25 mcg strength of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD. Both the 100/25 mcg and 200/25 mcg strengths of Relvar Ellipta have been approved in Japan for the treatment of asthma since 2013.
GSK and Theravance filed a regulatory submission for Relvar Ellipta for the treatment of COPD in 2012; withdrew the application in 2013; and re-filed in early 2016.
GSK Global Respiratory Franchise Senior VP and Head Eric Dube commented, “COPD affects people in different ways, and a range of treatments are needed so that physicians can determine the right treatment for the right patient. GSK has over 45 years of experience in delivering medicines that meet the individual needs of patients with respiratory diseases. We are delighted with this approval of Relvar Ellipta, our third COPD treatment to gain marketing authorization in Japan in under three years, and believe it will be an important new option for appropriate patients with COPD, as well as those with asthma.”
Innoviva CEO Mike Aguiar said, “The approval of Relvar Ellipta for COPD will provide Japanese physicians with a new, important once-daily, inhaled treatment option for appropriate patients. This represents yet another significant milestone in the respiratory partnership between Innoviva and GSK.”
Read the GSK and Innoviva press release.
