Posted by Michael Wonder on 23 Nov 2017
GSK submits landmark IMPACT data to US regulatory authority to support expanded label for Trelegy Ellipta
23 November 2017 - GlaxoSmithKline and Innoviva today announced the filing of a supplemental new drug application with the US FDA for the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patients with chronic obstructive pulmonary disease.
Approval of this application means futicasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) could be used by physicians to treat a wider population of patients with chronic obstructive pulmonary disease who are at risk of an exacerbation and require triple therapy.
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.
