TIDMGSK
RNS Number : 8237S
GSK PLC
14 March 2023
Issued: 14 March 2023, London UK
China National Medical Products Administration accepts
regulatory submission for Nucala (mepolizumab) in severe
eosinophilic asthma
GSK plc (LSE/NYSE: GSK) today announced that the China National
Medical Products Administration has accepted for review a new drug
application for Nucala (mepolizumab) as an add-on maintenance
treatment for severe eosinophilic asthma (SEA). If approved, Nucala
would be the first targeted anti-Interleukin-5 (IL-5) treatment in
China for adult and adolescent patients with this condition.
The application is based on positive data from a phase III trial
among Chinese patients(1) and the global SEA development programme,
which included three key clinical trials - DREAM(2) , MENSA(3) and
SIRIUS(4) - that established the efficacy and safety profile of
mepolizumab for severe eosinophilic asthma patients. The 52-week
phase III trial in Chinese patients studied the effect of
mepolizumab as adjunctive therapy in patients with SEA with a
primary endpoint of reduction, relative to placebo, in the annual
rate of clinically significant exacerbations.(1) The efficacy and
safety of mepolizumab in the Chinese population were shown to be
consistent with that in a non-Chinese population with SEA.(2-5)
Asthma affects an estimated 46 million adults in China, with 6%
experiencing severe asthma.(6-8)
Patients with SEA have an increased risk of exacerbations
requiring hospitalisation or an increased likelihood of a
potentially fatal asthma attack. (9,10) Guidelines for bronchial
asthma prevention and management (2020 edition) from the Asthma
group of the Chinese Thoracic Society reference the current unmet
need among Chinese patients with SEA.(11)
Nucala is currently approved in China for use in adults with
eosinophilic granulomatosis with polyangiitis (EGPA) and was
included on the National Reimbursement Drug List in January 2023.
However, Nucala is not currently approved in China for the
treatment of SEA.
About Nucala (mepolizumab)
First approved in 2015 for SEA in the US, Nucala is the
first-in-class monoclonal antibody to target IL-5. It is believed
to work by preventing IL-5 from binding to its receptor on the
surface of eosinophils, reducing blood eosinophils and maintaining
them within normal levels.(12)
Nucala has been studied in over 4,000 patients in 41 clinical
trials across several eosinophilic indications and was the first
treatment approved in the US across four eosinophil-driven
diseases: SEA, EGPA, hypereosinophilic syndrome and chronic
rhinosinusitis with nasal polyps. Nucala has been approved in the
US, the European Union and over 25 other markets as an add-on
maintenance treatment for patients with SEA.
About severe eosinophilic asthma
Severe asthma is defined as asthma which requires treatment with
high-dose inhaled corticosteroids plus a second controller (and/or
systemic corticosteroids) to prevent it from becoming
'uncontrolled' or which remains 'uncontrolled' despite this
therapy.(2-5) Severe asthma patients can also be categorised by
long-term oral corticosteroid use. In a sub-set of severe asthma
patients, the over-production of eosinophils (a type of white blood
cell) is known to cause inflammation in the lungs; this is known as
SEA.(2-5) IL-5 is the leading promoter of eosinophil growth,
activation and survival and provides an essential signal for the
movement of eosinophils from the bone marrow into the lung. The
majority (up to 80%) of severe asthma patients are eosinophilic,
according to a real-world observational study(13) .
About GSK
GSK is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together.
Find out more at gsk.com/company
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Risk factors" in the company's Annual Report on Form 20-F for
2022, GSK's Q4 Results for 2022 and any impacts of the COVID-19
pandemic.
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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. Efficacy 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 (2020 ). , 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.
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