GlaxoSmithKline and Theravance have submitted an application for the Anoro Ellipta umeclidinium bromide /vilanterol (UMEC/VI) DPI for the treatment of COPD to the Japanese Ministry of Health, Labour and Welfare (MHLW), the companies said. The submission in Japan is for 62.5/25mcg and 125/25mcg doses of UMEC/VI.
In the US, the Anoro Ellipta has a PDUFA date of December 18, 2013. In Europe, GSK and Theravance submitted an application for the inhaler in January 2013.
GSK says that it plans to begin regulatory submissions for UMEC monotherapy during 2013. An FDA advisory committee recently recommended approval of the Breo Ellipta fluticasone furoate/vilanterol dry powder inhaler.
Read the GSK and Theravance press release.
