Japanese approval for GSK's COPD drug; EU filling

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Relvar Ellipta (fluticasone furoate/vilanterol 100/25mcg) for the relief of various symptoms with chronic obstructive pulmonary disease (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required), UK pharma major GlaxoSmithKline (LSE: GSK) and its US partner Innoviva (Nasdaq: INVA) announced today.

Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate ‘FF’, and the long-acting beta2agonist (LABA), vilanterol ‘VI’. The approved dose of FF/VI in chronic obstructive pulmonary disease (COPD) is 100/25mcg administered once-daily using the Ellipta dry powder inhaler (DPI). Relvar Ellipta has been approved in Japan for the treatment of asthma since 2013 in two strengths – 100/25mcg and 200/25mcg.

Eric Dube, senior vice president and head of 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.”