According to GlaxoSmithKline and Innoviva, the European Commission has approved a label change for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, extending its use to patients with moderate to severe COPD who do not achieve adequate relief of symptoms with a dual bronchodilator. Trelegy Ellipta was approved in Europe in 2017 for COPD patients not adequately treated with ICS/LABA therapy.
In February 2018, the companies announced submission of a Type II variation application for expansion of the indication, and in September 2018, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the application.
GSK Chief Scientific Officer and President of R&D Hal Barron commented, “We are pleased that the European Commission has approved the expanded use of Trelegy Ellipta as this will enable even more COPD patients to benefit from this important medicine.”
Innoviva VP of Respiratory Medicine Paul Meunier said, “We are delighted that once-daily single inhaler triple therapy will now be available for COPD patients requiring a step up from dual bronchodilation, giving them a new option to help manage their disease.”
Read the GSK and Innoviva press release.
