GlaxoSmithKline and Innoviva have announced the submission of a supplemental New Drug Application for broader use of Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI for COPD based on data from the IMPACT study.
Trelegy Ellipta was initially approved by the FDA in September 2017 for COPD patients already using the Breo Ellipta fluticasone furoate/vilanterol DPI either alone or in combination with the Incruse Ellipta umeclidinium DPI.
The IMPACT study compared Trelegy Ellipta to Breo Ellipta and to Anoro Ellipta umeclidinium/vilanterol in more than 10,000 COPD patients and demonstrated a 15% reduction in exacerbations compared to Breo and 25% reduction compared to Anoro.
GSK President, R&D, Patrick Vallance commented, “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.”
Innoviva CEO Michael Aguiar said, “Trelegy Ellipta adds to the portfolio of Ellipta inhaled therapies, which has been developed because patients have different treatment needs. We believe the IMPACT data will provide clarity to physicians on how to treat patients based on their symptoms and risk profile and that Trelegy Ellipta will play an important role in treating patients who remain symptomatic and at risk of an exacerbation despite current therapy.”
Read the GSK and Innoviva press release.