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Nucala (Mepolizumab) Receives FDA Approval as First Biologic for COPD in Adults with Eosinophilic Phenotype

May 29, 2025 17:13 CST Updated 17:13
GSK

Pharmaceutical R&D Manufacturer

  • Nucala® is the only FDA-approved biologic proven in studies for use in a broad population of patients with chronic obstructive pulmonary disease (COPD) and blood eosinophil counts (BEC) ≥150 cells/μL across various eosinophilic phenotypes.
  • The approval was based on the positive results of the MATINEE and METREX Phase III trials.
  • MATINEE data show a reduction in acute exacerbations leading to hospitalization and/or emergency room visits.
  • Nearly 70% of COPD Patients in the U.S. with Poor Control After Receiving Inhalation Triple Therapy Have BEC≥150 Cells/μL4,5

GSK (LSE/NYSE: GSK) recently announced that the U.S. Food and Drug Administration (FDA) has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with chronic obstructive pulmonary disease (COPD) who have eosinophilic phenotype and inadequate disease control.

The FDA approval was based on the positive data from the MATINEE and METREX Phase III trials. In these trials, mepolizumab significantly reduced the annual rate of moderate to severe exacerbations in a broad population of patients with eosinophilic phenotype COPD compared to placebo, demonstrating both clinical and statistical significance.1,2Preventing acute exacerbations is a key goal in the treatment of chronic obstructive pulmonary disease (COPD).3 For patients, acute exacerbations are extremely harmful, as they are known to lead to irreversible lung damage, worsening symptoms, and increased mortality.3The incidence of adverse events was similar in the placebo group and the mepolizumab group.1,2

Currently completed Phase III clinical trial data indicate that Mepolizumab is the only FDA-approved biologic evaluated in patients with eosinophilic phenotype and blood eosinophil count (BEC) as low as ≥150 cells/μL.1,2BEC can be obtained through a simple blood test, which measures the level of eosinophils — a type of white blood cell that serves as a biomarker for type 2 inflammation and can indicate the patient's risk of exacerbation.3In the United States, approximately 70% of COPD patients with poorly controlled symptoms despite receiving inhaled triple therapy and experiencing persistent acute exacerbations have a BEC≥150 cells/μL.4,5This means that more than 1 million patients at risk of acute exacerbations, including those requiring emergency department visits and/or hospitalization, can consider mepolizumab as a new treatment option for COPD.4,5

Kaivan Khavandi, Global Head of Respiratory, Immunology and Inflammation R&D at GSK, Senior Vice President, stated: "The approval of Nucala in the United States provides an important treatment option for patients with chronic obstructive pulmonary disease (COPD). Long-term follow-up studies have shown that exacerbations are the single most important predictor of future risk, particularly for patients requiring hospitalization who face a very poor prognosis. Now, there is hope for improved treatment for eosinophilic phenotype COPD patients (including those with BEC as low as ≥150 cells/μL), who need new options like Nucala to support their treatment journey."

Jean Wright, MD, MBA, CEO of the COPD Foundation, stated: "COPD is not only a disease but also a relentless cycle. For patients with COPD, managing acute exacerbations remains an ongoing challenge even when receiving inhaled maintenance therapy. Biologics such as mepolizumab offer new hope for patients with COPD."

In the MATINEE and METREX trials, mepolizumab compared with placebo, as an add-on therapy to triple inhaled treatment (long-acting bronchodilator + inhaled corticosteroid) in patients with eosinophilic phenotype, significantly reduced the annualized rate of moderate to severe exacerbations (MATINEE: rate ratio [RR] 0.79, 95% confidence interval [CI] 0.66-0.94, p=0.01; METREX: rate ratio 0.82, 95% CI 0.68-0.98, adjusted p=0.04)¹². In the pre-specified secondary endpoints of MATINEE, the annualized rate of exacerbations requiring emergency department visits and/or hospitalizations was lower in the mepolizumab group than in the placebo group (rate ratio [RR] 0.65, 95% CI 0.43-0.96, but did not achieve statistical significance due to the hierarchical testing procedure where higher priority endpoints were not met)¹. COPD-related hospitalizations represent a significant healthcare challenge and are projected to become the leading cause of hospital admissions in the United States.⁶ Emergency department visits and hospitalizations already account for a large proportion of the annual direct medical costs of COPD, with the U.S. healthcare system spending approximately $7 billion annually on this condition.7

Mepolizumab has not yet been approved for use in COPD in any other countries. Regulatory authorities in China and Europe are reviewing the relevant applications.

About MATINEE And METREX

MATINEE and METREX are both Phase III, randomized (1:1), double-blind, parallel-group trials that evaluated the efficacy and safety of 100 mg subcutaneous mepolizumab administered every 4 weeks as an add-on therapy to placebo, on top of optimal inhaled triple therapy (dual long-acting bronchodilators plus inhaled corticosteroids).1,2

MATINEE Study Evaluates Mepolizumab in 804 COPD Patients with Evidence of Type 2 Inflammation (Blood Eosinophil Count ≥300 Cells/μL), Assessing the Efficacy and Safety of Mepolizumab over 52-104 Weeks. Patients may include those with clinical manifestations of chronic bronchitis, emphysema alone, or a combination of both, with severity ranging from moderate to very severe (stages 2-4 according to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] criteria). The full analysis of MATINEE included 403 patients in the mepolizumab group and 401 patients in the placebo group, all of whom had experienced exacerbations in the previous year despite optimized inhaled maintenance therapy.1

The full results of the MATINEE study were recently published in The New England Journal of Medicine, with more data presented at the 2025 American Thoracic Society International Conference, including subgroup analyses of patients with or without cardiovascular disease, different severities of prior exacerbations, and chronic bronchitis, emphysema alone, or both conditions combined.1

METREX Trial: Evaluating the 52-week efficacy and safety of Mepolizumab in 836 patients (randomized 1:1), divided into eosinophilic phenotype group (blood eosinophil count ≥150 cells/μL at enrollment or ≥300 cells/μL in the past year) and non-eosinophilic phenotype group (blood eosinophil count <150 cells/μL at enrollment and no evidence of ≥300 cells/μL in the past year).

The results of the METREX study were published in The New England Journal of Medicine in 2017.2

About COPD

COPD is a progressive, heterogeneous inflammatory lung disease, including chronic bronchitis and/or emphysema.3

More than 390 million people worldwide suffer from COPD, which is the third leading cause of death.8,9COPD patients experience persistent respiratory symptoms such as shortness of breath, coughing, and sputum production, along with progressive airflow obstruction caused by chronic inflammation, impacting daily life.3

Despite the use of triple inhaled therapy, many patients continue to experience persistent symptoms and disease exacerbation.10 Acute exacerbations are events of acute worsening of symptoms in COPD, which can lead to hospitalization and irreversible lung damage.3Early intervention is crucial for preventing acute exacerbations and cumulative lung injury.3

About Nucala

Nucala is a monoclonal antibody that specifically binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. Nucala has been developed to treat a range of IL-5-mediated diseases associated with type 2 inflammation.

Currently, it has been approved in Europe for the treatment of four IL-5 mediated diseases and in the United States for five such diseases.

AboutGSKBreathing

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 committed to improving treatment outcomes and quality of life for patients with all types of asthma, COPD, refractory cough that remains poorly understood, or rare diseases such as systemic sclerosis associated with interstitial lung disease. GSK is harnessing cutting-edge technologies with the aim of addressing underlying disease dysfunction and preventing disease progression.

AboutGSK

GSK is a global biopharmaceutical company with the mission of "uniting science, technology, and talent to work together to overcome diseases." For more information, please visitwww.gsk.com

References

  1. Sciurba F, et al. Mepolizumab to prevent exacerbations in COPD with an eosinophilic phenotype. N Engl J Med. Apr 2025;392:1710-1720. Available at nejm.org.
  2. Pavord ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI: 10.1056/NEJMoa1708208.
  3. Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2025 Gold Report. Available at: goldcopd.org. Last accessed May 2025.
  4. GSK, Optum Analysis DOF (DOF 2024N562932_00).
  5. Müllerová H, et al. Exacerbations and health care resource use among patients with COPD in relation to blood eosinophil counts. Int J Chron Obstruct Pulmon Dis. 2019;14:683-692. DOI: 10.2147/COPD.S194367.
  6. Khakban A, et al. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291. DOI: 10.1164/rccm.201606-1162PP.
  7. American Lung Association (ALA). COPD Trends Brief – Burden. Available at: Lung.org. Last accessed: May 2025.
  8. Adeloye D, et al. 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;10(5):447-458. DOI: 10.1016/S2213-2600(21)00511-7.
  9. Chen S, et al. The global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a health-augmented macroeconomic modelling study. Lancet Glob Health. 2023;11(8):e1183-e1193. DOI: 10.1016/S2214-109X(23)00217-6.
  10. Chen S, Miravitlles M, Rhee CK, et al. Patients with Chronic Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance Therapy. Int J Chron Obstruct Pulmon Dis. 2022 Sep 9;17:2187–2200. DOI: 10.2147/COPD.S378649