The European Commission expanded the label of GlaxoSmithKline/Innoviva’s once-daily Trelegy Ellipta, making it the first single inhaler triple therapy indicated for maintenance of 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 beta-agonist (LABA).
GSK noted that while bronchodilation is recognised as the foundation of COPD therapy, “many patients may continue to struggle with symptoms and exacerbations over time”.
The expanded indication for Trelegy Ellipta “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 firm added.
The label update is based on data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study, which showed Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), 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”.
“We are delighted that once-daily single inhaler triple therapy will now be available for COPD patients requiring a step up from dual bronchodilation, giving them a new option to help manage their disease,” commented Dr. Paul Meunier, VP, Respiratory Medicine at Innoviva.
Trelegy Ellipta was originally approved in EU in November last year 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.