GSK Plc Nucala COPD submission accepted by FDA

GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for the use of Nucala (mepolizumab), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA) date is 7 May 2025.

·   Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations compared with placebo

·   Nucala could be the first approved biologic with monthly dosing for patients with COPD

·   COPD affects more than 14 million people in the US with estimates of 500,000 hospitalisations and up to 1.3 million emergency department visits each year

The submission is based on data from the MATINEE study, which evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterised by blood eosinophil count.¹ The trial recruited COPD patients with broad clinical presentations including hard to treat patients with emphysema-only, chronic bronchitis only, or a mix of both. The MATINEE study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.

IL-5 is a key cytokine (protein) in type 2 inflammation, an inflammatory process exhibited in up to 40% of patients with COPD and the underlying pathobiology that drives symptoms and exacerbations.^2-4 Type 2 inflammation is typically detected by blood eosinophil count, a biomarker, which can be measured by a simple blood test. This test can help indicate a COPD patient’s risk of exacerbation and deterioration, their response to treatment, and inform treatment strategies in these patients.⁵  

COPD affects more than 390 million people globally and over 14 million people in the US, exerting a significant burden on healthcare resources and the lives of patients.^6-9 Recurrent exacerbations add to pressures on healthcare systems and account for a large proportion of the annual direct medical costs of COPD with emergency department visits and inpatient care costing the US healthcare system around $7 billion a year.^6,8,9   

The full results of MATINEE will be presented at a future scientific congress and form the basis of regulatory submissions around the world.

Nucala is currently approved for use in the US across four IL-5 mediated conditions. These include two respiratory  indications as an add-on maintenance treatment for patients with severe asthma with an eosinophilic phenotype aged 6 years and older and as an add-on maintenance treatment for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and inadequate response to nasal corticosteroids. Indications also include the use of Nucala for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) and for the treatment of patients ages 12 years and older with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.¹² Nucala is currently not indicated for COPD anywhere in the world.

References

1. ClinicalTrials.gov. Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level (MATINEE) Available at: https://clinicaltrials.gov/study/NCT04133909. Last accessed November 2024.
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. GOLD Science Committee Members (2023-2024). The Global Strategy for Diagnosis, Management and Prevention of CO 2024. Available at: www.goldcopd.org Last accessed: November 2024.
6. 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.
7. Boers E, et al. Global Burden of Chronic Obstructive Pulmonary Disease Through 2050. JAMA Netw Open. 2023;6(12).
8. CDC. Trends in the Prevalence of Chronic Obstructive Pulmonary Disease Among Adults Aged ≥18 Years – United States, 2011-2021. Weekly / November 17, 2023 / 72(46);1250-1256. Available at; Trends in the Prevalence of Chronic Obstructive Pulmonary Disease Among Adults Aged ≥18 Years – United States, 2011-2021 | MMWR (cdc.gov) Last accessed: November 2024.
9. American Lung Association. COPD Trends Brief – Burden. Available at: https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-burden Last accessed: November 2024.
10. Press VG, et al. Preventing COPD Readmissions Under the Hospital Readmissions Reduction Program: How Far Have We Come? Chest. 2021;159(3):996-1006.
11. Ruan, H, et al. Readmission rate for acute exacerbation of chronic obstructive pulmonary disease: A systematic review and meta-analysis. Respir. Med. 2023, 206, 107090.
12. U.S. Food and Drug Administration. Nucala Full Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf. Last accessed November 2024.

GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next generation standard of care, and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD along with less understood refractory chronic cough or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim to modify underlying disease dysfunction and prevent disease progression.