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GlaxoSmithKline to file application for COPD drug in Japan

Michele Maatouk

LONDON (ShareCast) - (ShareCast News) - GlaxoSmithKline (Other OTC: GLAXF - news) and Theravance (NasdaqGS: THRX - news) intend to file a supplemental new drug application with the Japanese regulatory authority in the first quarter of 2016 for Relvar Ellipta, which is used for the treatment of chronic obstructive pulmonary disease. The pharmaceuticals company said the decision follows results from a phase III efficacy and safety study involving 1,620 patients, 370 of whom were from Japan, which showed that patients who received the Relvar Ellipta combination achieved a statistically significant improvement in lung function.

Glaxo said full results from the study will be the subject of a future publication or presentation.

At 0830 BST, shares in Glaxo were down 0.5% at 1,268.07p.