Nucala (mepolizumab) application for COPD accepted for review in China
- Around 100 million people live with COPD in China, accounting for almost 25% of all COPD cases globally
- Submission based on data from MATINEE trial, which showed a significant and clinically meaningful reduction in rate of moderate/severe exacerbations with Nucala compared to placebo
- Data includes positive results in the broadest COPD population studied with a biologic, including those with chronic bronchitis, emphysema only, or both Nucala could be the first approved biologic with monthly dosing for patients with COPD
GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has accepted for review the new drug application for the use of Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
IL-5 is a key cytokine (protein) in type 2 inflammation which is an underlying driver in many diseases. 2-4 This type of inflammation is detected in up to 40% of patients with COPD and is a major cause of symptoms and exacerbations that can lead to hospitalisation and/or emergency room visits.2-4
COPD affects more than 390 million people globally, with research estimating that approximately 100 people in China live with COPD, which accounts for almost 25% of the global COPD cases.5,6 This puts a significant burden on healthcare resources and the lives of patients, with recurrent exacerbations accounting for a large proportion of the annual direct medical costs of COPD due to emergency department visits and inpatient care.5-7 This burden is expected to dramatically increase due to the rapidly aging population in China.6,7
Nucala’s application was supported by results from the positive Phase III MATINEE trial which showed a significant and clinically meaningful reduction in rate of moderate/severe exacerbations with Nucala compared to placebo. The trial recruited a wide spectrum of COPD patients including those with chronic bronchitis, emphysema-only or both.1 These data indicate that Nucala, in addition to inhaled maintenance therapy, offers a clinically meaningful benefit to a patient population in need of treatments to reduce their risk of exacerbations.
If approved, Nucala could be the first approved biologic with monthly dosing for patients with COPD.
Nucala is currently approved for use in the China across three IL-5 mediated conditions. These include two respiratory indications as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older and as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Indications also include the use of Nucala for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
Nucala is currently not approved for use in COPD in any country.
References
1. ClinicalTrials.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. World Health Organisation (WHO).Advancing COPD care in China through a comprehensive approach. Available at: https://www.who.int/. Last accessed February 2025
7. 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.