GlaxoSmithKline plc (LSE:GSK) and Innoviva have announced that the planned submission of an NDA for a triple therapy DPI for the treatment of COPD has been moved up from the first half of 2018 to the end of 2016, following discussions with the FDA. The fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) combination is delivered using the Ellipta inhaler. The companies also confirmed that they expect to file a marketing application for the product in the EU by the end of 2016.
GSK said that it currently has sufficient data from its ongoing clinical program, which includes the FULFIL (Lung FUnction and quality of LiFe assessment in COPD with closed trIpLe therapy) and IMPACT (InforMing the PAthway of COPD Treatment) studies.
The IMPACT study began in 2014 and was expected to enroll 10,000 patients in 38 countries. Initiation of the FULFIL study was announced in February 2015, with an expected enrollment of 1,800 patients.
Read the GSK and Innoviva press release.
