GSK Announces NMPA Acceptance of Nucala (Mepolizumab) New Drug Application for Eosinophilic COPD in China
Feb 20, 2025 21:44
CST Updated
21:44
GSK
Pharmaceutical R&D Manufacturer
February 20, 2025, London, UK — GSK announced that the China National Medical Products Administration has accepted the new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for patients with eosinophilic phenotype chronic obstructive pulmonary disease (COPD).
The Status of COPD in China
Number of Patients: Approximately 100 million people in China suffer from COPD, accounting for nearly 25% of global COPD cases. Disease BurdenCOPD has a significant impact on healthcare resources and patients' lives, with emergency visits and hospitalizations due to recurrent exacerbations accounting for a large proportion of the annual direct medical costs of COPD. With the rapid aging of China's population, this burden is expected to increase significantly.
Clinical Trial Data of Nucala
MATINEE Trial: The application for Nucala is based on the positive results of the MATINEE Phase III clinical trial, which showed that, compared to placebo, Nucala significantly reduced the rate of moderate/severe exacerbations. Wide-ranging research population: The study covered a wide range of COPD patient populations, including those with chronic bronchitis, emphysema only, or both conditions. Potential Clinical SignificanceNucala is expected to become the first approved monthly dosing biologic for COPD.
Mechanism of Action of Nucala
Targeting IL-5Nucala is a monoclonal antibody that targets interleukin-5 (IL-5), a key cytokine in type 2 inflammation. Type 2 inflammation is detected in up to 40% of COPD patients and is a major cause of symptoms and exacerbations. Existing IndicationsNucala has been approved in China for three IL-5 mediated diseases, including add-on maintenance treatment for severe eosinophilic asthma, add-on treatment for chronic rhinosinusitis with nasal polyps, and the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).
About the MATINEE Trial
Experimental DesignMATINEE is a Phase III, randomized (1:1), double-blind, parallel-group trial that evaluated the efficacy and safety of Nucala 100 mg as an add-on treatment, administered subcutaneously every 4 weeks for 52-104 weeks, compared to placebo, in 804 patients with COPD. Primary Endpoint: Compared with placebo, Nucala significantly reduced the annualized rate of moderate/severe exacerbations, reaching the primary endpoint.
GSK's Commitment in the Respiratory Field
Innovation and R&D: GSK continues to be committed to improving the quality of life for asthma and COPD patients through innovative vaccines, targeted biologics, and inhaled medications. Future Outlook: GSK is committed to using the latest science and technology to modify the fundamental mechanisms of diseases and prevent their progression.
About COPD and Type 2 Inflammation
Disease OverviewCOPD is a progressive and heterogeneous inflammatory lung disease, including chronic bronchitis and/or emphysema, affecting more than 390 million people worldwide and being the third leading cause of death. Acute Exacerbation: Acute exacerbation is an acute worsening of COPD symptoms, which may lead to hospitalization and irreversible lung damage, accelerate disease progression, and increase the risk of hospitalization.
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