GSK files at FDA for expanded use of Trelegy Ellipta for maintenance treatment of COPD.

GlaxoSmithKline plc and Innoviva, Inc. announced the filing of a supplemental New Drug Application (sNDA) with the FDA for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, �FF/UMEC/VI�) for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD).

Approval of this sNDA means FF/UMEC/VI could be used by physicians to treat a wider population of patients with COPD who are at risk of an exacerbation and require triple therapy. FF/UMEC/VI is the first treatment to provide a combination of three molecules in a single inhaler that only needs to be taken once a day. It contains an inhaled corticosteroid, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, delivered once daily in GSK�s Ellipta dry powder inhaler, which is used across the entire new portfolio of inhaled COPD medicines.

Comment: In the IMPACT study FF/UMEC/VI showed superiority to the dual combination therapies (FF/VI and UMEC/VI) on multiple endpoints, including exacerbation rates, lung function and health related quality of life. This builds on substantial evidence from across multiple clinical programmes that has demonstrated the benefit of the molecules in FF/UMEC/VI both alone and in combination, for the treatment of COPD.