Combo drug for brochodilation in EU

January 14, 2019 0 By FM

The European Commission has authorised an expanded label for once-daily fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’ (Trelegy Ellipta) for patients with moderate to severe chronic obstructive pulmonary disease (COPD) not adequately treated with dual bronchodilation or with an inhaled corticosteroid (ICS) and a long-acting ß2-agonist (LABA).

Bronchodilation is recognised as the foundation of COPD therapy. However, many patients may continue to struggle with symptoms and exacerbations over time. The expanded indication for the triple-drug regimen reflects the evidence supporting its potential benefits in a broader group of patients than originally indicated, giving them the option of taking a once-daily single inhaler triple therapy for the first time.

The label update is based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to both the ICS/LABA Relvar/Breo Ellipta (FF/VI) and long-acting muscarinic receptor antagonist (LAMA)/LABA Anoro Ellipta (UMEC/VI) in patients with moderate to severe COPD on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health-related quality of life.