VCBeat Health Contact Us
Home GSK’s Nucala (Mepolizumab) Receives CDE Acceptance for New Indication in Eosinophilic COPD in China

GSK’s Nucala (Mepolizumab) Receives CDE Acceptance for New Indication in Eosinophilic COPD in China

Feb 20, 2025 16:24 CST Updated 16:24
GSK

Pharmaceutical R&D Manufacturer

  • China has approximately 100 million patients with chronic obstructive pulmonary disease, accounting for nearly 25% of the total global cases of chronic obstructive pulmonary disease.
  • According to MATINEE1The data from the study showed that Nucala demonstrated significant and clinically meaningful efficacy in reducing the annualized rate of moderate/severe acute exacerbations compared to placebo.
  • The MATINEE study is the most extensive research among COPD biologics studies in terms of the inclusion of COPD patient populations. The positive results of this study include data from patients with the chronic bronchitis phenotype, the pure emphysema phenotype, and those with both clinical phenotypes.
  • Nucala is expected to become the first approved once-a-month treatment.COPDBiological agents provide patients with a new treatment option.

GSK (LSE/NYSE: GSK) announced today that the China National Medical Products Administration has accepted the new drug application for Nucala (mepolizumab injection, a monoclonal antibody targeting interleukin-5) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Interleukin-5 (IL-5) is a key cytokine in type 2 inflammation, which is a potential driving factor behind various diseases.2-4The incidence of this type of inflammation in patients with chronic obstructive pulmonary disease (COPD) is as high as 40%, and it has become a major trigger for symptom exacerbation and acute episodes, potentially leading to hospitalization and/or emergency department visits.2-4   

Chronic obstructive pulmonary disease (COPD) affects more than 390 million people worldwide. Studies show that newly diagnosed cases, existing cases, and deaths in China account for 24%, 21%, and 32% of the global totals, respectively, making it a leading cause of death and disability in China.5-7 This places a significant burden on healthcare resources and seriously impacts patients' quality of life. Emergency department visits and hospitalizations due to recurrent acute exacerbations account for a high proportion of the annual direct medical costs associated with COPD.5-7With the rapid aging of China's population, the burden is expected to further increase.6,7

Based on the positive results of the MATINEE Phase 3 study, Nucala demonstrated significant and clinically meaningful efficacy in reducing the rate of moderate to severe exacerbations compared to placebo. The study enrolled a broad range of patients with chronic obstructive pulmonary disease (COPD), including those with chronic bronchitis and/or emphysema.1Data show that, on the basis of maintenance treatment with inhaled formulations, Nucala provides clinically meaningful additional benefits for patients who need to reduce the risk of acute exacerbations.

If approved, Nucala could become the first once-a-month biologic for COPD.

Nucala has been approved in China for the treatment of three diseases mediated by IL-5. The specific indications include two respiratory diseases: one is for the maintenance treatment of severe eosinophilic asthma (SEA) in adults and adolescents aged 12 years and above; the other is as an add-on maintenance treatment to intranasal corticosteroids for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled by systemic corticosteroids and/or surgery. In addition, Nucala has also been approved for the treatment of adult eosinophilic granulomatosis with polyangiitis (EGPA).

Nucala is not yet approved for the treatment of chronic obstructive pulmonary disease (COPD) in any country.

 

Clinical Research Project on Nucala for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Mepolizumab Injection was first approved in the United States in 2015 for the treatment of severe eosinophilic asthma. The drug is a monoclonal antibody that specifically targets and binds to interleukin-5 (IL-5), a signaling protein (cytokine) that plays a key role in type 2 inflammation.8Nucala has been developed for the treatment of a range of IL-5 mediated diseases associated with type 2 inflammation.8  

Mepolizumab Injection conducted three clinical studies on COPD. The first two studies, METREX and METREO, were completed in 2017. The MATINEE study aims to enrich and refine the findings of METREX and METREO. Building on the previous two studies and incorporating advancements in the IL-5 scientific field, it identifies the patient population that would benefit the most from Nucala treatment. It also provides support for subsequent regulatory submissions and approvals for this indication.

MATINEE is a Phase 3, randomized (1:1), double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of Mepolizumab Injection (100 mg) as an add-on therapy. Administered as a subcutaneous injection every 4 weeks for 52-104 weeks, the therapy is added to a triple inhaled regimen consisting of long-acting dual bronchodilators plus inhaled corticosteroids. The study enrolled 804 patients with chronic obstructive pulmonary disease (COPD) who had a history of exacerbations and type 2 inflammation, characterized by elevated blood eosinophil levels.1

MATINEE Study Meets Primary Endpoint: Nucala, in Addition to Inhaled Maintenance Therapy, Significantly Reduces Annualized Rate of Moderate/Severe Exacerbations Compared to Placebo, with Statistically and Clinically Significant Differences. This Efficacy Was Validated in Patients Treated for 52-104 Weeks.

Data from the MATINEE study will be presented at future scientific conferences or published in peer-reviewed journals. Global regulatory submissions containing MATINEE data are currently underway.

 

Regarding Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation

Chronic Obstructive Pulmonary Disease (COPD) is a progressive and heterogeneous inflammatory lung disease, encompassing clinical phenotypes such as chronic bronchitis and/or emphysema. COPD affects more than 390 million people worldwide and is the third leading cause of death globally.5,10Each year, the disease causes more than 3 million deaths. Patients with COPD often experience persistent respiratory symptoms such as shortness of breath, coughing, and sputum production, as well as airflow obstruction caused by chronic inflammation. These symptoms can severely impact the daily lives of patients.10

An acute exacerbation refers to a rapid deterioration of symptoms in chronic obstructive pulmonary disease (COPD). Such episodes may lead to hospitalization and cause irreversible lung damage, resulting in progressive decline in lung function.10-12Repeated acute exacerbations can accelerate disease progression and further increase the risk of hospitalization. Patients may need to visit the emergency department and require inpatient treatment, thereby placing additional pressure on the healthcare system.10-12For patients, this may lead to a deterioration of their overall health condition, creating a vicious cycle that exacerbates symptoms, reduces quality of life, and increases the risk of death.10-12

Despite the use of inhaled triple therapy, many patients continue to experience symptoms and exacerbations, indicating the need for targeted treatments that address the underlying pathophysiological mechanisms associated with disease progression.10-13Researchers observed permanent and irreversible tissue damage in advanced patients, making it difficult to further improve respiratory symptoms and enhance quality of life. Therefore, early intervention becomes extremely crucial to prevent acute exacerbations and cumulative lung injury.10

Current evidence suggests that, in addition to its effects on eosinophils, IL-5 also has broad effects on other structural cells and immune cells; it has also been shown that these cells promote inflammation, which may lead to airway remodeling and disease progression.2,3 14-19Current research is accumulating more evidence to gain a deeper understanding of the functions of these cells and their potential impact on clinical outcomes in patients with respiratory diseases. Type 2 inflammation is a key driver underlying the functional abnormalities in various immune-mediated conditions. IL-5 is a central cytokine in type 2 inflammation.2-4The presence of type 2 inflammation can be identified by the count of eosinophils in the blood.2-4

 

About GSK Respiratory

Building on decades of pioneering work, GSK continues to help hundreds of millions of patients achieve higher treatment goals by developing a new generation of standardized treatment solutions and redefining the future of respiratory disease care. With an industry-leading portfolio of respiratory products and a robust pipeline of vaccines, targeted biologics, and inhaled therapies, we are focused on improving treatment outcomes and quality of life for patients with all types of asthma, chronic obstructive pulmonary disease (COPD), refractory cough that remains poorly understood, or rare conditions like systemic sclerosis-associated interstitial lung disease. GSK is leveraging cutting-edge science with the aim of addressing underlying disease dysfunction and preventing disease progression.

 

About GSK

GSK is a global biopharmaceutical company with the mission to "unite science, technology, and talent to push boundaries and overcome diseases together." For more information, please visit www.gsk.com.

 

References

  1. gov. Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level. Available at: https://clinicaltrials.gov/study/NCT04133909 Last accessed February 2025
  2. Saha S, et al. Eosinophilic airway inflammation in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):39-47.
  3. Maspero J, et al. Type 2 inflammation in asthma and other airway diseases. ERJ Open Res. 2022;8:00576-2021.
  4. Singh D, et al. Eosinophilic inflammation in COPD: prevalence and clinical characteristics. Eur Respir J. 2014;44:1697-1700.
  5. Adeloye D, et al. NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458.
  6. Yin P, et al. The Burden of COPD in China and Its Provinces: Findings From the Global Burden of Disease Study 2019. Front Public Health. 2022 Jun 3;10:859499.
  7. Wang, X. et al.Treatment patterns for chronic obstructive pulmonary disease under the tiered medical system. Sci Rep 15, 844 (2025).
  8. Nucala US information available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf last accessed February 2025
  9. Pavord ID, et al. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770.
  10. The Global Strategy for Diagnosis, Management and Prevention of COPD 2024. Available at: goldcopd.org Last accessed: November 2024.
  11. Hurst J R, et al. Susceptibility to Exacerbation in Chronic Obstructive Pulmonary Disease. N Engl J Med. 2010;363:1128-38.
  12. Whittaker H, et al. Frequency and Severity of Exacerbations of COPD Associated with Future Risk of Exacerbations and Mortality: A UK Routine Health Care Data Study. Int J Chron Obstruct Pulmon Dis. 2022;17:427-437.
  13. Rabe KF, et al. Targeting Type 2 Inflammation and Epithelial Alarmins in Chronic Obstructive Pulmonary Disease: A Biologics Outlook. Am J Respir Crit Care Med. 2023;208(4):395-405.
  14. Buchheit KM, et al. Mepolizumab targets multiple immune cells in aspirin-exacerbated respiratory disease. J Allergy Clin Immunol. 2021;148(2):574-584.
  15. Barretto KT, et al. Human airway epithelial cells express a functional IL-5 receptor. Allergy. 2020;75(8):2127-2130.
  16. Bajbouj K, et al. IL-5 receptor expression in lung fibroblasts: Potential role in airway remodelling in asthma. Allergy. 2023;78(3):882-885.
  17. Siddiqui S, et al. Eosinophils and tissue remodeling: Relevance to airway disease. J Allergy Clin Immunol. 2023;152(4):841-857.
  18. Bergantini L, et al. Regulatory T cell monitoring in severe eosinophilic asthma patients treated with mepolizumab. Scand J Immunol. 2021;94(1):e13031.
  19. Pavord ID, et al. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770.