14 February 2018 - GlaxoSmithKline and Innoviva today 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.

Approval of the submission would mean FF/UMEC/VI, the only once-daily single inhalation triple therapy for the treatment of chronic obstructive pulmonary disease, 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.

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.

Read GSK press release