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GSK triple combo COPD therapy shows superiority in Phase III trials

Published on 20/06/16 at 09:06am

GlaxoSmithKline (LSE: GSK), along with Innoviva (NASDAQ: INVA), have presented positive top-line results from a pivotal Phase III trial for a triple combination therapy for chronic obstructive pulmonary disease (COPD).

The once-daily combination of fluticasone furoate/umedclidinium/vilanterol represented a treatment containing an inhaled corticosteroid, long-acting muscarinic antagonist and long-acting beta agonist. COPD is a more severe form of asthma that is characterised by obstruction to airflow that interferes with normal breathing. It is estimated it affects as many as 329 million people worldwide.

In the late-stage FULFIL trial, the treatment combo met its two co-primary endpoints, in demonstrating significant improvements in lung function and health-related quality of life compared with twice-daily Symbicort Turbohaler (budesonide/formoterol).

Dave Allen, head of respiratory R&D at GSK, says: “We are delighted with the outcome of the FULFIL study. Triple combination therapy is already a reality for many patients with COPD and is dispensed in multiple inhalers. By combining three medicines in a single inhaler we can offer a convenient, once-daily dosing option to patients while improving their symptoms.”

The findings from this trial are expected to support GSK’s plans for an EU regulatory submission of the closed triple combination therapy for COPD which is expected by the end of 2016. The company has also signalled intentions to submit a new drug application to the US Food and Drug Administration by the close of the year.

Sean Murray

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