According to GSK, the Chinese National Medical Products Administration (NMPA) has approved 100/62.5/25 mcg and 200/62.5/25 mcg strengths of Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI for the treatment of adult patients with asthma. The lower dose of Trelegy was approved in China for the treatment of COPD in 2019.
GSK noted that the Chinese approval was based on data from the Phase 3 Captain study, which was completed in 2019. The US FDA expanded the use of Trelegy Ellipta to add the asthma indication in 2020, and Singapore’s Health Sciences Authority (HSA) approved the expanded indication in 2024.
GSK Senior VP, Global Head, Respiratory, Immunology and Inflammation, R&D Kaivan Khavandi commented, “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.”
Read the GSK press release
