BRIEF—GSK bids to broaden label for Trelegy Ellipta in the USA

GlaxoSmithKline has filed a supplemental New Drug Application in the USA for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol).

The company is bidding to broaden the label to include maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

R&D president Patrick Vallance said: “Data from GSK’s landmark IMPACT study provide important information on the efficacy and safety of these molecules combined in a single inhaler and the benefit they can bring to appropriate patients when delivered as a triple combination therapy. We have moved swiftly to file these data with the FDA.”