Relvar Ellipta Approved in Japan for Treatment of Asthma

GlaxoSmithKline plc GSK and Theravance, Inc. THRX today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved RELVAR™ ELLIPTA™ for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required). Relvar Ellipta is not indicated for the treatment of chronic obstructive pulmonary disease (COPD) in Japan. Relvar is a combination of the inhaled corticosteroid (ICS), fluticasone furoate "FF", and the long-acting beta2 agonist (LABA), vilanterol "VI". The MHLW has approved two doses of FF/VI - 100/25 mcg and 200/25 mcg. Both strengths will be administered once-daily using the Ellipta, a new dry powder inhaler (DPI). Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, "The approval of Relvar Ellipta in Japan means that, for the first time, people with asthma will be able to benefit from a once-daily ICS/LABA that delivers continuous 24-hour efficacy. Throughout the development programme, GSK focused on the needs of patients to develop a medicine that may help address some of the existing treatment challenges. We are delighted by this approval, which means that healthcare professionals in Japan will soon have another treatment option for appropriate asthma patients." "The approval of Relvar Ellipta will provide Japanese physicians with a new, important once-daily, inhaled treatment option for their asthma patients," said Rick E Winningham, Chief Executive Officer of Theravance. "This first approval of Relvar Ellipta in asthma represents yet another significant milestone in the respiratory partnership between Theravance and GSK." Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $10 million (USD) to GSK following MHLW approval of Relvar Ellipta in Japan. FF/VI is not approved or licensed anywhere outside of Japan for the treatment of asthma.