GlaxoSmithKline (GSK) and Innoviva on Friday announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved lung disease drug Relvar Ellipta, known in the U.S. as Breo Ellipta, for the relief of various symptoms with chronic obstructive pulmonary disease (COPD).
Relvar Ellipta has been approved in Japan for the treatment of asthma since 2013 in two strengths – 100/25 mcg and 200/25 mcg.
Eric Dube, SVP & Head, GSK Global Respiratory Franchise, said: “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 authorisation 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.”
Mike Aguiar, CEO of Innoviva, 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.”
About Relvar Ellipta
Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate “FF”, and the long-acting beta2 agonist (LABA), vilanterol ‘VI’. The approved dose of FF/VI in COPD is 100/25 mcg administered once-daily using the Ellipta dry powder inhaler (DPI).
Relvar Ellipta (FF/VI) was approved for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required) in Japan in 2013.