GlaxoSmithKline and Innoviva have announced that GSK has filed an MAA with the European Medicines Agency for its fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD. In November 2016, GSK submitted an NDA for the FF/UMEC/VI product in the US.
GSK Head, Respiratory Therapy Area Unit, R&D, Dave Allen said, “Many patients with COPD are already at an advanced stage when they are diagnosed. Prescribing patterns show the importance of having a range of options available to meet the differing needs of individual patients. An approval of our closed triple therapy in Europe would complement our portfolio of inhaled therapies designed for once-daily dosing in a single inhaler, offering patients a convenient, alternative option.”
Innoviva CEO Mike Aguiar commented, “The EU filing of the closed triple combination is the latest development in our long-standing collaboration with GSK. If approved, FF/UMEC/VI as once daily triple combination in a single inhaler could be a meaningful addition to the treatment options available for advanced COPD patients.”
Read the GSK and Innoviva press release.
