GlaxoSmithKline plc and Innoviva Inc today announced the filing by GSK of 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 (COPD). 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 amaintenance 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.
Dave Allen, Head, Respiratory Therapy Area Unit, R&D, 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.”
Mike Aguiar, CEO of Innoviva, Inc., added “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.”
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.