GSK Submits FDA New Drug Application for COPD Triple Combination Therapy

GlaxoSmithKline (GSK), together with Innoviva, recently announced GSK submitted a New Drug Application (NDA) with the U.S. FDA for the triple combination therapy FF/UMEC/VI (fluticasone furoate/umeclidinium/vilanterol) to treat chronic obstructive pulmonary disease (COPD). GSK announced earlier this year that it was planning to advance the timing of the filing with…

Triple Combination Therapy Shows Promise in COPD; Superior to Symbicort/Turbohaler Therapies

GlaxoSmithKline and Innoviva announced positive data from the Phase 3 FULFIL clinical trial evaluating their investigational triple combination therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/IV) in patients with chronic obstructive pulmonary disease (COPD). FULFIL is a randomized, double-blind, multicenter study designed to evaluate the efficacy and safety of a daily dose of the FF/UMEC/IV…