GlaxoSmithKline, Innoviva Offer Regulatory Update on US Filing Plans for Closed Triple Combo Therapy FF/UMEc/VI for Patients with COPD

GlaxoSmithKline plc

and Innoviva, Inc.

today announced that, following discussions with the US Food and Drug Administration (FDA), GSK has brought forward the plan to file a New Drug Application (NDA) in the US for the once-daily closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; a combination inhaled corticosteroid, longacting muscarinic antagonist, long-acting beta agonist) for patients with chronic obstructive pulmonary disease (COPD). The US regulatory submission is now anticipated by the end of 2016, rather than the first half of 2018, as previously expected. The NDA for the closed triple combination therapy will comprise data now in hand from the closed triple combination therapy development programme, as well as data from studies with FF, UMEC and VI either alone or in combination. The companies continue to expect an EU regulatory submission of the closed triple combination therapy for COPD by the end of 2016.