GlaxoSmithKline files for European approval of COPD therapy

GlaxoSmithKline has applied for European regulatory approval of a new chronic obstructive pulmonary disease (COPD) therapy.

A regulatory submission has been filed with the European Medicines Agency for a closed triple combination therapy consisting of fluticasone furoate, umeclidinium and vilanterol, following on from a similar application for the same regimen in the US last month.

To be delivered once daily using GlaxoSmithKline's Ellipta dry powder inhaler, the therapy has demonstrated symptom relief benefits in the phase III FULFIL study, as well as a number of other trials.

Regulatory submissions of the closed triple therapy are anticipated in the rest of the world beginning in 2017. To date, this promising regimen has not yet been approved in any territory.

Dave Allen, head of respiratory therapies for GlaxoSmithKline's research and development unit, said: "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."

COPD is thought to affect around 329 million people worldwide and is characterised by obstruction to airflows, interfering with normal breathing.

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