GSK and Innoviva have announced positive top-line results from the pivotal phase III FULFIL study which shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in chronic obstructive pulmonary disease (COPD) patients.
The investigational once-daily ‘closed’ triple combination therapy, fluticasone furoate/umeclidinium/vilanterol, is a combination inhaled corticosteroid, long-acting muscarinic antagonist, long-acting beta agonist.
At the end of the 24-week study period the trial met its two co-primary endpoints, demonstrating statistically significant improvements compared with twice-daily Symbicort® Turbohaler® (budesonide/formoterol 400/12mcg) in both lung function and health-related quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ).
Dave Allen, Head of Respiratory R&D at GSK, said: “We are delighted with the outcome of the FULFIL study, which marks a further step towards making this closed triple combination therapy available to appropriate patients with COPD. 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.”
Mike Aguiar, CEO of Innoviva, said: “ If approved, a once-daily triple combination would be an important addition to our portfolio of combination respiratory products partnered with GSK including Relvar®/Breo® Ellipta® and Anoro® Ellipta.”
Data support regulatory submission by GSK in Europe by end of 2016. Meanwhile, GSK’s US filing plans remain on track with submission also expected by end of 2016.