GSK reported a new indication approval from China’s National Medical Products Administration (NMPA) for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol; FF/UMEC/VI), given the nod to treat adults with uncontrolled asthma. That adds to the drug’s existing chronic obstructive pulmonary disease (COPD) indication and means it is the first and only approved once-daily single-inhaler triple therapy (SITT) for both COPD and asthma in China.

The approval was supported by data from the global CAPTAIN study, a randomized, double-blind, active-controlled, six-arm Phase III trial that enrolled 2,436 patients across 15 countries whose asthma remained uncontrolled on inhaled corticosteroid/long-acting beta₂-agonist (ICS/LABA) therapy. In the study, triple therapy with FF/UMEC/VI delivered statistically significant improvements in lung function (change from baseline forced expiratory volume in one second, FEV₁) compared with ICS/LABA (FF/VI), with mean gains of about 110 ml for the 100/62.5/25 µg dose and 92 ml for the 200/62.5/25 µg dose versus their respective FF/VI comparators (both p < 0.0001).

Trelegy Ellipta’s SITT combines an inhaled corticosteroid (fluticasone furoate) with a long-acting muscarinic antagonist (umeclidinium) and a long-acting beta₂-agonist (vilanterol) in a once-daily dry-powder inhaler. The therapy was first approved in China in 2019 for maintenance treatment of COPD and now also holds an asthma indication with available strengths of 100/62.5/25 mcg for both COPD and asthma and 200/62.5/25 mcg for asthma only. GSK highlighted China’s 46-million strong adult asthma population, with around 50% experiencing uncontrolled symptoms despite treatment.

Research context

Once-daily SITT is now a cornerstone in the management of moderate-to-severe asthma and chronic obstructive pulmonary disease (COPD), especially for patients inadequately controlled on dual therapy.

The global SITT market is dominated by three major products: Trelegy Ellipta, AstraZeneca’s Breztri Aerosphere (budesonide / glycopyrrolate / formoterol fumarate), and Chiesi’s Trimbow (beclometasone dipropionate / formoterol / glycopyrronium). Each has broad regulatory approvals and robust clinical data supporting their use in COPD, while Trelegy and Breztri are also approved for asthma in several regions.

SITT offers significant advantages over multiple-inhaler triple therapy (MITT), including improved adherence, reduced exacerbations, and better patient satisfaction, which are supported by real-world and clinical trial data. The competitive landscape is characterized by ongoing head-to-head trials, regional differences in regulatory approvals, and payer-driven access rules, with emerging competition from Novartis (Enerzair Breezhaler) and pipeline assets.