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GlaxoSmithKline and Theravance, Inc. joined 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 (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 whoreceived 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.
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