2 December 2016 - GlaxoSmithKline and Innoviva today announced the filing by GSK of a regulatory submission with the EMA for once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for patients with chronic obstructive pulmonary disease. 

This follows the announcement of the submission of a New Drug Application for FF/UMEC/VI in the US in November 2016.

The closed triple combination therapy comprises three medicines: fluticasone furoate, an inhaled corticosteroid (ICS), umeclidinium, a long-acting muscarinic antagonist (LAMA) and vilanterol, a long-acting beta2-adrenergic agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler.

The EU regulatory submission of closed triple therapy comprises a marketing authorisation application for a maintenance treatment to relieve symptoms of adult patients with chronic obstructive pulmonary disease. It is based on data from the closed triple combination therapy development programme including data from the phase III FULFIL study, as well as data from studies with FF, UMEC and VI either alone or in combination.

Read GSK press release