GlaxoSmithKline and Innoviva have filed for approval in the US of a new once-daily, triple combination therapy for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), some 18 months earlier than originally planned.
The closed combination consists of three medicines: the inhaled corticosteroid (ICS) fluticasone furoate; a long-acting muscarinic antagonist (LAMA) umeclidinium; and long-acting beta2-adrenergic agonist (LABA) vilanterol, delivered once-daily in GSK's Ellipta dry powder inhaler.
Earlier this year, the firms unveiled data from the FULFIL study showing statistically significant improvements with the triple therapy compared with the dual therapy Symbicort Turbohaler (budesonide/formoterol) in both lung function, as measured by trough FEV1 (+171 mL), and health-related quality of life, as measured by the St. George's Respiratory Questionnaire (-6.6 versus -4.3, respectively).
Also, the study showed a statistically significant and clinically meaningful reduction in the annual rate of moderate/severe exacerbations with FF/UMEC/VI compared to Symbicort Turbohaler, with closed triple therapy showing a 35 percent reduction based on data up to 24 weeks and a 44 percent reduction in the subset of patients that received treatment for up to 52 weeks.
"To observe such significant reductions in exacerbations with closed triple therapy versus budesonide/formoterol is encouraging and supports our belief that a convenient, once-daily triple therapy dosing option delivered via a single inhaler could provide compelling and clinically important treatment benefits," said Dave Allen, Head of Respiratory R&D at GSK, commenting on the results at the time.
A regulatory filing in the EU is also planned in the coming weeks, with other submissions in other countries beginning next year.