NMPA Accepts New Indication Application for Nucala® (Mepolizumab) as Add-on Maintenance Treatment for Severe Eosinophilic Asthma in China
GSK
Pharmaceutical R&D Manufacturer
ShanghaiMarch 14, 2023PR Newswire -- GSK recently announced that the National Medical Products Administration (NMPA) of China has accepted Nucala®(Generic name: Mepolizumab Injection) has submitted a new indication application for use as an add-on maintenance treatment for severe eosinophilic asthma. If approved, Nucala...®Will become the first targeted human anti-interleukin-5 (IL-5) monoclonal antibody biologic in China for adult and adolescent patients with severe eosinophilic asthma.
This application is based on the Phase III clinical trial of mepolizumab conducted in the Chinese population for severe eosinophilic asthma.[1]And the positive results achieved in the global development program. The global development program includes three key clinical trials, namely DREAM.[2]、MENSA[3]And SIRIUS[4], to determine the efficacy and safety of Mepolizumab in treating patients with severe eosinophilic asthma. The Phase III clinical trial in the Chinese population, with a 52-week treatment period, aims to study the effect of Mepolizumab as add-on maintenance therapy for patients with severe eosinophilic asthma. The primary endpoint is a clinically significant reduction in the rate of asthma exacerbations compared to the placebo group.[1]. The results indicate that the efficacy and safety of Mepolizumab in the Chinese study population are consistent with those observed in other countries.[2]-[5]。
It is estimated that there are approximately 46 million asthma patients among Chinese adults, of which 6% are severe asthma patients.[6]-[8]Patients with severe eosinophilic asthma may require hospitalization due to serious deterioration of their condition, and it can even be life-threatening.[9],[10]Mepolizumab is recommended by the Chinese Medical Association's Respiratory Diseases Branch Asthma Group in the Chinese Bronchial Asthma Prevention and Treatment Guidelines (2020 Edition) for Chinese patients with severe eosinophilic asthma.[11]。
Nucala®Has been approved in China for the treatment of adult Eosinophilic Granulomatosis with Polyangiitis (EGPA), and was officially included in the National Medical Insurance Catalog in January 2023. Currently, Nucala®The indication for severe eosinophilic asthma has not been approved in mainland China.
About Nucala®(Generic Name: Mepolizumab Injection)
As the world's first approved monoclonal antibody biologic targeting human interleukin-5 (IL-5), Nucala®First approved in the U.S. in 2015 for the treatment of severe eosinophilic asthma. Nucala®By binding to IL-5, it blocks the binding of IL-5 to the surface receptors on eosinophils, thereby reducing and maintaining the number of eosinophils in the blood at normal levels.[12]。
Nucala®Evaluated in over 4,000 patients across 41 clinical trials for various eosinophilic conditions. In the U.S., it became the first drug approved to treat four inflammatory diseases caused by eosinophilia: severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps. To date, Nucala...®Approved in the U.S., Europe, and more than 25 other markets as a combination maintenance therapy for patients with severe eosinophilic asthma.
About Severe Eosinophilic Asthma
Severe asthma is defined as asthma that requires high-dose inhaled corticosteroids combined with a second control medication (and/or systemic corticosteroids) to maintain "control," or remains "uncontrolled" despite such therapy.[2]-[5]Patients with severe asthma can also be classified based on their long-term use of oral corticosteroids. Among patients with severe asthma, there is a subtype whose pulmonary inflammation is caused by an excessive number of eosinophils (a type of white blood cell), and these patients are referred to as having severe eosinophilic asthma.[2]-[5]Interleukin-5 (IL-5) is the major cytokine promoting maturation, functional activation, and survival of eosinophils, and it provides crucial signals for eosinophil migration from the bone marrow to the lungs and other organs. According to a real-world observational study[13]Up to 80% of severe asthma cases are eosinophilic asthma.
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 visitgsk.com/company
References
1. A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma (NCT03562195) available at A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma - Full Text View - ClinicalTrials.gov last accessed February 2023
2. Pavord, I. D. et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. The Lancet. 2012. 380, ISSUE (9842) 651-659
3. Ortega, H.G et al Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma. N Engl J Med 2014; 371:1198-1207
4. Bell, E.H. et al. Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma. N Engl J Med 2014; 371:1189-1197. DOI: 10.1056/NEJMoa1403291
5. Chupp GL, et al. Efcacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma
(MUSCA): a randomised, double-blind, placebo-controlled, parallel group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390–400. Su N, et. al. Chin J Intern Med.2016, 55(12):917-921.
6. Huang K, Yang T, Xu J, et al. Prevalence, risk factors, and management of asthma in China: a national cross-sectional study. Lancet. 2019; 394:407-418.
7. Ding B, Small M, Wang W, et al. The disease burden of mild asthmatics in China. European Respiratory Journal. 2016; 48 (suppl 60): PA4208
8. National Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma (EPR-3). [Online]. Available at: https://www.nhlbi.nih.gov/health-topics/guidelines-for-diagnosis-management-of-asthma. [Accessed February 2023]
9. Ambrosino, N and Paggiaro, P. The management of asthma and chronic obstructive pulmonary disease: current status and future perspectives Expert Rev. Respir. Med. 6(1), 117–127 (2012)2012;
10. Antonicelli, L et al. Asthma severity and medical resource utilisation. Eur Respir J 2004; 23: 723–729
11. China Asthma Guideline 2020 Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition). Chinese Journal of Tuberculosis and Respiratory Diseases, 43(12), 26
12. European summary of product characteristics available at https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf last accessed February 2023
13. Azim A, et al. Clinical evaluation of type 2 disease status in a real-world population of difficult to manage asthma using historic electronic healthcare records of blood eosinophil counts. Clin Exp Allergy. 2021 Jun;51(6):811-820.