GSK seeks EU approval for inhaled triple combo COPD therapy

The company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg).

The company submitted its MAA in the US several weeks ago. Further applications in other markets are due to be made in 2017.

The therapy features three medicines including 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.

Data collected from the candidate’s phase 3 FULFIL study and also from studies on using FF, UMEC and VI individually or in combination have paved way for the EU submission, said GSK.  

GSK respiratory therapy area unit R&D head 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.”

In another development, GSK had announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its candidate fluticasone furoate / vilanterol 100/25 mcg branded as Relvar Ellipta for relieving various COPD symptoms.

Relvar is a combination of the ICS, fluticasone furoate, and the long-acting beta2 agonist, vilanterol VI.

The approved dose of FF/VI in COPD is 100/25 mcg administered once-daily using the Ellipta dry powder inhaler. Relvar Ellipta has been approved in Japan to treat asthma since 2013 in two strengths – 100/25 mcg and 200/25 mcg.