According to GlaxoSmithKline and Innoviva, the FDA has approved an expanded indication for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, allowing the use of Trelegy Ellipta for COPD patients with airflow limitation or with acutely worsening respiratory symptoms.
GSK filed an sNDA for Trelegy Ellipta in November 2017 based on data from the IMPACT study. Trelegy Ellipta was initially approved by the FDA in September 2017. In Europe, Trelegy Ellipta was approved in November 2017, and GSK submitted a Type II variation application for expanded use in February 2018.
GSK Chief Scientific Officer and President of Research and Development Hal Barron said, “Following the initial approval of Trelegy Ellipta in September, we have analyzed the data from the IMPACT study and identified additional benefits that this important medicine offers patients with chronic obstructive pulmonary disease. 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. We will continue to analyze the data from the IMPACT trial and our ongoing Trelegy Ellipta studies to demonstrate further the value of this important medicine to patients.”
Innoviva Senior VP and Chief Scientific Officer Ted Witek commented, “Up to half of patients with COPD on maintenance therapy will have experienced at least one exacerbation in the past 12 months, so gaining an indication that reflects the role Trelegy Ellipta can play in reducing this risk is important. We welcome this regulatory update which will allow physicians to offer the benefits of once-daily single inhaler triple therapy to appropriate patients with COPD.”
Read the GSK and Innoviva press release.
