China’s National Medical Products Administration (NMPA) has approved a new indication for GSK's Trelegy Ellipta for the treatment of adults aged 18 years and older with uncontrolled asthma.
The approval expands its existing use in chronic obstructive pulmonary disease (COPD), making Trelegy Ellipta the first and only single-inhaler triple therapy approved in China for the maintenance treatment of both asthma and COPD.
The decision introduces an important new option for patients with uncontrolled asthma, a major unmet need in the country. Approximately 46 million adults in China live with asthma, and nearly half experience uncontrolled symptoms despite standard treatment, increasing the risk of exacerbations and reduced quality of life.
The approval is supported by data from GSK’s CAPTAIN study, which evaluated Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol; FF/UMEC/VI) in patients whose asthma remained inadequately controlled on inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) therapy. The study demonstrated that Trelegy Ellipta delivered significant improvements in lung function compared with dual therapy, highlighting the benefit of triple therapy in suitable patients.
CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active-controlled, global multicentre study conducted across 15 countries, enrolling 2,436 patients. Participants received once-daily treatment across six study arms. Results showed statistically significant improvements in forced expiratory volume in one second (FEV₁), with increases of 110 ml and 92 ml in key treatment comparisons versus dual therapy.
With this approval, Trelegy Ellipta is now authorised in China at the 100/62.5/25 mcg strength for both asthma and COPD, while the 200/62.5/25 mcg strength is approved for asthma only. The inhaler was first approved in China in 2019for long-term, once-daily maintenance treatment of COPD.
Trelegy Ellipta combines three established respiratory medicines in a single inhaler taken once daily, integrating an inhaled corticosteroid, a long-acting muscarinic antagonist, and a long-acting beta₂-agonist. The expanded indication reinforces its role in addressing persistent respiratory disease and reflects growing clinical emphasis on simplified, single-inhaler treatment strategies for patients with uncontrolled asthma.
