Trelegy Ellipta filed with EMA for label expansion in chronic obstructive pulmonary disease.- GlaxoSmithKline + Innoviva.

GlaxoSmithKline and Innoviva announced the submission of the landmark IMPACT data to the European Medicines Agency as part of a type II variation to support an expanded label for Trelegy Ellipta (fluticasone furoate /umeclidinium/vilanterol, �FF/UMEC/VI�) in Europe for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD). The regulatory submission is primarily based on data from the IMPACT study showing FF/UMEC/VI was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA), Relvar/Breo (FF/VI), and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist (LAMA/LABA), Anoro (UMEC/VI), on a range of clinically important endpoints, including reducing the number of exacerbations or �flare ups� patients experienced, and improving lung function and health related quality of life.

The filing in Europe follows submission of a supplemental New Drug Application (sNDA) to the FDA which is currently under review. Also included in the European submission are data showing FF/UMEC/VI was non-inferior to UMEC and FF/VI when used in combination in terms of improving lung function, quality of life and breathlessness, further adding to the evidence base. Approval of the submission would mean FF/UMEC/VI, the only once-daily single inhalation triple therapy for the treatment of COPD, could be used by physicians to treat a wider population of patients with the condition who are at risk of an exacerbation and require triple therapy.