The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding GSK’s MAA for its triple combination fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD in patients whose symptoms are not adequately controlled by an ICS/LABA combination. GSK plans to market the product in Europe as Trelegy Ellipta if approved.
GSK filed the MAA for the triple combination DPI in December 2016, the month after the company filed an NDA for the product in the US. Marketing applications for DPI have also been submitted in Australia and Canada.
The application is supported by data from the from the FULFIL study, which compared the fluticasone furoate/umeclidinium/vilanterol DPI to Symbicort for the treatment of COPD. Earlier this year, Boehringer Ingelheim filed a citizen petition in the US challenging GSK’s NDA on the grounds that the FULFIL study does not meet the requirements of the Combination Rule.
GSK President of R&D Patrick Vallance commented, “We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers.”
Innoviva CEO Mike Aguiar said, “This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS/LABA treatment that require additional bronchodilation. Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”
Read the GSK and Innoviva press release.
