By VETTAPHARMA reporter: GSK plc announced that China’s National Medical Products Administration (NMPA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of adults aged 18 years and older with uncontrolled asthma in China. The decision expands on the inhaler’s existing license for chronic obstructive pulmonary disease (COPD) and makes it the first and only single-inhaler triple therapy (SITT) approved in the country for the long-term management of both conditions.
Trelegy Ellipta combines three active ingredients — an inhaled corticosteroid (FF), a long-acting muscarinic antagonist (UMEC), and a long-acting beta2-adrenergic agonist (VI) — in a once-daily dry powder inhaler. It is approved in 100/62.5/25 mcg strength for both asthma and COPD, and in 200/62.5/25 mcg strength for asthma only.
The CAPTAIN study, which supported the approval, was a global, randomized, double-blind, active-controlled trial involving 2,436 patients across 15 countries. Participants were assigned to one of six treatment arms comparing FF/UMEC/VI versus FF/VI in adults whose asthma remained inadequately controlled on standard inhaled corticosteroid/long-acting beta agonist (ICS/LABA) regimens. Data showed significant improvements in lung function — with mean increases in forced expiratory volume (FEV1) of 110 mL and 92 mL for two different FF/UMEC/VI dose levels compared with FF/VI (p < 0.0001 for both comparisons).
Asthma affects an estimated 46 million adults in China, with about half experiencing uncontrolled symptoms, increasing their risk of exacerbations and impacting quality of life. GSK described the approval as an important option for patients whose condition is not adequately managed with existing treatments.
GSK first received NMPA approval for Trelegy Ellipta in 2019 for COPD. The new asthma indication further broadens the product’s role in the Chinese respiratory market, aligning with the company’s focus on advancing respiratory care options for patients.
Source credit:
- GSK plc. (2026, January 23). Trelegy Ellipta approved in China for use in adults with uncontrolled asthma [Press release]. GSK. Click here
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