LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) and Innoviva, Inc. (INVA) reported positive top-line results from the phase III FULFIL study of the investigational triple combination therapy, fluticasone furoate/umeclidinium/vilanterol, in patients with chronic obstructive pulmonary disease. The company said the study met its two co-primary endpoints, demonstrating statistically significant improvements compared with twice-daily Symbicort Turbohaler in both lung function, at the end of the 24-week study period.
The company said the findings from the FULFIL study support GSK's plans for an EU regulatory submission of the closed triple combination therapy for chronic obstructive pulmonary disease which is expected by the end of 2016. GSK also intends to submit a New Drug Application for the closed triple combination therapy in COPD to the US FDA by the end of 2016.
Copyright RTT News/dpa-AFX