GlaxoSmithKline and Innoviva have submitted new data to regulators in the US in support of expanding the label of Trelegy Ellipta in chronic obstructive pulmonary disease.
The drugmakers have submitted a supplemental New Drug Application (sNDA) for use of the therapy - which combines fluticasone furoate, umeclidinium and vilanterol (FF/UMEC/VI) in a single haler - for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients COPD.
Approval would allow Trelegy Ellipta to be used by physicians to treat a wider population of patients with COPD who are at risk of an exacerbation and require triple therapy.
“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,” said Patrick Vallance, president of R&D at GSK.
In the IMPACT study 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, the firms noted.
FF/UMEC/VI was approved for use in the US on in Septmember 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). If approved, the sNDA would broaden this indication.
In Europe the therapy was cleared last week as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.