GSK & Theravance To File SJNDA For Relvar Ellipta In Japan - Quick Facts

(RTTNews) - GlaxoSmithKline (GSK.L, GSK) and Theravance, Inc. (THRX) announced the intention to file a supplemental Japanese New Drug Application (sJNDA) for Relvar Ellipta (fluticasone furoate vilanterol or, FF/VI) for the treatment of chronic obstructive pulmonary disease with the Japanese regulatory authority during the first quarter of 2016. The decision follows results from an additional global phase III efficacy and safety study.

The study showed that patients who received FF/VI 100/25mcg achieved a statistically significant improvement in lung function compared with VI 25mcg at 12 weeks.