GlaxoSmithKline and Theravance have announced plans to file a supplemental Japanese New Drug Application for the Relvar/Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD in the first quarter of 2016. The Japanese MHLW approved Relvar Ellipta for the treatment of asthma in patients 15 years old and older in September 2013.
The companies also announced data from a Phase 3 trial of Relvar Ellipta that included Japanese COPD patients. Of the 1620 COPD patients in the study comparing FF/VI with vilanterol alone, 370 were from Japan. The study showed a statistically significant improvement in trough FEV1 for patients who received FF/VI 100/25mcg compared to those who received VI alone.
Read the GSK/Theravance press release.
