Triple combination therapy (umeclidinium bromide+vilanterol+ fluticasone) filed with EMA for chronic obstructive pulmonary disease- GlaxoSmithKline

GlaxoSmithKline has filed its triple combination therapy (umeclidinium bromide+vilanterol+ fluticasone) with the European Medicines Agency as a treatment for patients with chronic obstructive pulmonary disease (COPD). The therapy is comprised of three medicines: fluticasone furoate (FF), an inhaled corticosteroid (ICS), umeclidinium (UME), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA), delivered via GSK's Ellipta dry powder inhaler.

The application is based on the FULFIL study which showed 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.

Comment: GSK filed the triple therapy last month in the US.