BRIEF—Once-daily Trelegy Ellipta gains expanded COPD indication in Europe

The European Commission has authorized an expanded label for once-daily Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), which is marketed by UK pharma major GlaxoSmithKline.

This approval recognizes the drug’s effect on exacerbations and makes it the first single inhaler triple therapy indicated 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 β2-agonist (LABA), says GSK.

It was developed in partnership with USA-based Innoviva.

Dr Hal Barron, chief scientific officer and president, R&D, at GSK, said, “We are pleased that the European Commission has approved the expanded use of Trelegy Ellipta as this will enable even more COPD patients to benefit from this important medicine.”

While bronchodilation is recognized 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 companies said.