US regulators have approved GlaxoSmithKline and Innoviva’s Trelegy Ellipta to treat a wider population of chronic obstructive pulmonary disease (COPD) patients.
The approval allows use of the therapy - which combines fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI) in a single inhaler – for maintenance treatment of airflow obstruction and reduction of exacerbations in patients with COPD.
The new indication enables physicians to prescribe Trelegy Ellipta for a broader population of patients with COPD who are at risk of an exacerbation and require triple therapy.
The decision rides on the back of data from the IMPACT study, in which Trelegy Ellipta 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.
It also follows the therapy’s original approval for the long-term, once-daily, maintenance treatment of COPD patients who are receiving Breo (FF/VI) and require additional bronchodilation or who are receiving Breo and Incruse (UMEC).
“We are pleased that the robust data from the IMPACT study has enabled the expanded indication announced today and the FDA action has been taken so swiftly,” noted Dr Hal Barron, chief scientific officer and president of research and revelopment, GSK.
“We will continue to analyse the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients.”