GlaxoSmithKline to file application for COPD drug in Japan
GlaxoSmithKline and Theravance 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.
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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.