GlaxoSmithKline plc and Innoviva, Inc. 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) (for the relief of symptoms and reduction of exacerbations, see section 5.1).
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.
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.
Dave Allen, Head, Respiratory Therapy Area, R&D, GSK said, “This filing is primarily based on the IMPACT study, which clarifies the type of patient most likely to benefit from once-daily single inhaler triple therapy, and adds to the evidence supporting the clinical profile of Trelegy Ellipta. The submission reflects our confidence in this medicine, which we believe has the potential to be an effective treatment option for appropriate patients with COPD who require triple therapy for symptom relief and exacerbation reduction.”
FF/UMEC/VI was approved in Europe in November 2017 as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA.
The filing in Europe follows submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (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 (NCT02729051).
Dr. Theodore J. Witek Jr., Senior Vice President and Chief Scientific Officer of Innoviva added, “The data included in this submission build on existing evidence supporting the role of once-daily single inhaler triple therapy in the treatment of appropriate patients with COPD. If approved, updates to the Trelegy Ellipta labelling will give clinicians additional information to help guide their treatment choices.”
