Glaxosmithkline, Theravance Intend to File Relvar Ellipta for COPD in Japan

GlaxoSmithKline (LSE/NYSE: GSK) and Theravance, Inc.

today announced the intention to file a supplemental Japanese New Drug Application (sJNDA) for Relvar® Ellipta® (fluticasone furoate "FF"/vilanterol "VI" or "FF/VI") for the treatment of chronic obstructive pulmonary disease (COPD) with the Japanese regulatory authority during the first quarter of 2016. This decision follows results from an additional global phase III efficacy and safety study. As previously announced, Study 200820 was designed to provide additional data for the combination, FF/VI, compared with its component, VI, in Japanese patients with COPD, as there were insufficient efficacy data in this specific COPD patient group within the FF/VI phase III clinical development programme. The study which included 1620 patients with COPD, of whom 370 were from Japan, showed that patients who received FF/VI 100/25mcg achieved a statistically significant improvement in lung function (as measured by change from baseline in trough FEV1) compared with VI 25mcg at 12 weeks (p=0.001). The most frequently reported adverse events in the study (greater than or equal to 3% in any group) were nasopharyngitis (6% VI, 6% FF/VI), COPD exacerbation (4% VI, 2% FF/VI) and headache (2% VI, 4% FF/VI). Pneumonia as an adverse event of special interest was reported in 7 subjects in each treatment group (<1% VI, <1% FF/VI). The full results from the study will be the subject of a future publication / presentation. Study Design The 12-week, phase IIIa, multi-centre, randomised, stratified (reversibility status), double-blind, parallel-group study evaluated the contribution of FF 100mcg to FF/VI 100/25mcg once daily to lung function (as measured by trough FEV1) by comparison with VI 25mcg, in patients with moderate to severe COPD. Patients enrolled in the study were required to have had at least one COPD exacerbation that required systemic/oral corticosteroids and/or antibiotics and/or hospitalisation in the 12 months prior to screening and current symptoms of COPD, defined as a combined symptom score (combination of breathlessness, cough, sputum, and night-time awakenings requiring treatment with albuterol [salbutamol]) of ≥4 on at least 5 of the 7 days immediately preceding the Randomisation Visit. Patients in the study were randomised 1:1 to receive FF/VI 100/25 mcg or VI 25 mcg. All treatments were administered once daily in the dry powder inhaler (DPI) Ellipta®. The study was conducted in 11 countries, with 23% of patients from Japan. The study is listed on www.clinicaltrials.gov (NCT02105974). FF/VI is not currently indicated for the treatment of COPD in Japan. FF/VI was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the regular treatment of asthma in patients aged 15 years and older in September 2013. Relvar Ellipta, or FF/VI, is also known as Breo Ellipta in some other markets, including the US.