GSK's Trelegy Ellipta Receives Expanded COPD Indication in Europe
The European Commission has approved an expanded label for GSK's once-daily Trelegy Ellipta, recognizing its effect on exacerbations for patients with chronic obstructive pulmonary disease (COPD). It is now indicated for patients not adequately treated by dual bronchodilation.
GSK plc announced on November 9, 2018, that the European Commission has authorized an expanded indication for the once-daily Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol). This approval acknowledges the therapy's impact on COPD exacerbations.
The expanded indication establishes Trelegy Ellipta as the first single-inhaler triple therapy specifically indicated for patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated with dual bronchodilation. It also applies to those not managed by a combination of an inhaled corticosteroid (ICS) and a long-acting beta-2-agonist (LABA).
This regulatory update is supported by data from the pivotal IMPACT study (Informing the Pathway of COPD Treatment). The study demonstrated that Trelegy Ellipta was superior to other therapies, including Relvar/Breo Ellipta (FF/VI) and Anoro Ellipta (UMEC/VI), in patients with moderate to severe COPD. Key findings included a reduction in exacerbations, improved lung function, and enhanced quality of life.
Trelegy Ellipta combines fluticasone furoate (an ICS), umeclidinium (a long-acting muscarinic antagonist), and vilanterol (a long-acting beta2-agonist) in a single inhaler. GSK plc is a global healthcare company focused on science-led innovation.