5 December 2016 - - UK-based pharmaceutical company GlaxoSmithKline plc (NYSE: GSK) has filed a regulatory submission with the European Medicines Agency 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, the company said.

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

Closed triple combination therapy comprises three medicines, including fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2-adrenergic agonist, 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 COPD.

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.

Regulatory submissions of closed triple therapy for COPD are anticipated in the rest of the world beginning in 2017. The closed triple combination of FF/UMEC/VI is not approved for use anywhere in the world.

GSK's partner, Innoviva, is focused on bringing compelling new medicines to patients in areas of unmet need by leveraging its significant expertise in the development, commercialization and financial management of bio-pharmaceuticals.

Innoviva's portfolio is anchored by respiratory assets partnered with Glaxo Group Ltd., including Relvar/Breoellipta and Andoro Ellipta, which were jointly developed by Innoviva and GSK.

Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from Relvar/Breoellipta, Andoro Ellipta and, if approved and commercialised, VI monotherapy, as well.

In addition, Innoviva retains a 15% economic interest in future payments made by GSK for earlier-stage programs partnered with Theravance Biopharma, Inc., including the closed triple combination therapy for COPD.