GlaxoSmithKline and Innoviva have announced the submission of a type II variation application seeking expanded use for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) DPI for the treatment of COPD. Trelegy Ellipta was granted marketing authorization in Europe in November 2017.
In the US, the FDA initially approved Trelegy Ellipta for the treatment of COPD patients already using the Breo Ellipta fluticasone furoate/vilanterol DPI either alone or in combination with the Incruse Ellipta umeclidinium DPI in September 2017, and GSK filed an sNDA for expanded use of Trelegy Ellipta in November 2017.
Both the type II variation application and the sNDA are supported by data from the IMPACT study, which demonstrated improved lung function and a reduction in exacerbations for patients using Trelegy Ellipa compared to Relvar (Breo) Ellipta FF/VI and Anoro Ellipta UMEC/VI.
GSK Head of the Respiratory Therapy Area, R&D, Dave Allen, commented, “This filing is primarily based on the IMPACT study, which clarifies the type of patient most likely to benefit from once-daily single inhaler triple therapy, and adds to the evidence supporting the clinical profile of Trelegy Ellipta. The submission reflects our confidence in this medicine, which we believe has the potential to be an effective treatment option for appropriate patients with COPD who require triple therapy for symptom relief and exacerbation reduction.”
Innoviva Senior VP and Chief Scientific Officer Theodore J. Witek Jr. said, “The data included in this submission build on existing evidence supporting the role of once-daily single inhaler triple therapy in the treatment of appropriate patients with COPD. If approved, updates to the Trelegy Ellipta labelling will give clinicians additional information to help guide their treatment choices.”
Read the GSK and Innoviva press release.
