GlaxoSmithKline and Innoviva have won European approval for the novel triple therapy inhaler Trelegy Ellipta, offering a new treatment option for patients with Chronic Obstructive Pulmonary Disorder (COPD).
Trelegy Ellipta combines three active molecules - fluticasone furoate, umeclidinium, vilanterol (FF/UMEC/VI), found in Breo Ellipta and Incruse Ellipta - in the same inhaler.
The European Commission has cleared Trelegy Ellipta as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
The decision follows a recent marketing recommendation by the European Medicines Agency’s CHMP, based on 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.
“We believe this is an important innovation in COPD management and look forward to making it available for appropriate patients with COPD,” noted Eric Dube, Senior Vice President & Head, GSK Global Respiratory Franchise.
The first European launch is expected to take place before the end of the year.
The therapy won clearance in the US in September.