GlaxoSmithKline plc (GSK) and Innoviva, Inc. (INVA) announced that they had received the approval of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) from the European Medicines Agency. The drug is approved for asthma. The product is once-daily, single-inhaler triple therapy for treating adults who have asthma.
The approval was based on the Phase III CAPTAIN study. The study included 2,436 adult patients across 15 countries. The target population includes patients whose disease remained inadequately controlled despite treating with an inhaled corticosteroid and a long-acting β2-agonist. The drug was compared with fluticasone furoate /vilanterol. Trelegy Ellipta showed significant improvement in lung function compared with Relvar/Breo Ellipta.
European Medicines Agency has earlier approved the product for treating patients with Chronic Obstructive Pulmonary Diseases (COPD) who are inadequately controlled with an inhaled corticosteroid and a long-acting β2-agonist.
The US FDA accepted submission for the treatment of adult patients with asthma in December 2019 and Japan by the Ministry fo Health, Labour, and Welfare in November 2019.
About Trelegy Ellipta:
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is a triple combination single inhaler, indicated once a day. The drug is approved in Europe in November 2017 for chronic obstructive pulmonary disease (COPD).