Trelegy Ellipta approved in China for use in adults with uncontrolled asthma – GSK

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 patients with asthma aged 18 years and older, adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country.

Approval was based on GSK’s CAPTAIN study which showed that in patients uncontrolled on inhaled corticosteroids/long-acting beta agonist (ICS/LABA), the additional bronchodilation provided by FF/UMEC/VI demonstrated significant improvements in lung function compared with FF/VI.

Kaivan Khavandi, Senior Vice President, Global Head, Respiratory, Immunology and Inflammation, R&D said: “Early intervention with a single inhaler triple therapy can improve clinical outcomes for suitable patients with uncontrolled asthma. Today’s approval gives patients whose condition is not optimally managed, and therefore at increased risk of experiencing exacerbations, an important option in their care. As a company, we are committed to help change the course of disease and make clinical remission, where patients’ disease has sustained control, an ambitious but attainable treatment goal.”

Asthma is one of the most prevalent chronic respiratory diseases in China, with approximately 46 million adults affected nationwide. Despite established treatment recommendations, around half of patients experience uncontrolled symptoms, increasing the likelihood of exacerbations and reduced quality of life. This new indication for their already established single-inhaler triple therapy (SITT)  in COPD presents an important option for patients with uncontrolled asthma in China who would benefit from an ICS/LAMA/LABA in a once-daily inhalation.

FF/UMEC/VI is now approved by NMPA in 100/62.5/25mcg strength for both asthma and COPD indications and in 200/62.5/25mcg strength for asthma only.

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication. In the study, 2,436 patients were treated across 15 countries with approximately 400 patients randomly assigned to each of the six treatment arms.

Data from the study demonstrated mean (95% confidence interval) improvements in FEV1 change from baseline of 110ml for FF/UMEC/VI 100/62.5/25 μg versus FF/VI 100/25 μg (95% CI 66-153; p<0.0001) and 92ml for FF/UMEC/VI 200/62.5/25 μg versus FF/VI 200/25 μg (49-135; p<0.0001).