a1393z
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of January 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 10 January 2024, London UK
Nucala (mepolizumab)
approved in China for use in severe asthma with an eosinophilic
phenotype
●
Mepolizumab
is the first targeted anti-Interleukin-5 (IL-5) biologic available
in China as an add-on maintenance treatment for severe eosinophilic
asthma
●
Asthma
is a major health priority in China with millions affected by
severe disease
●
Approval
based on a separate phase III trial among Chinese
patients reinforcing
mepolizumab's efficacy
and safety data
GSK plc (LSE/NYSE: GSK)
today announced
that the China National Medical Products
Administration has approved Nucala (mepolizumab) as
an add-on maintenance treatment for severe eosinophilic asthma in
adults and adolescents aged 12 years and older. Nucala is the
first anti-Interleukin-5 (IL-5) targeting treatment approved for
use in China for
adult and adolescent patients with this
condition.
Asthma is a major health burden in China affecting an estimated 46
million adults.1 Of
those, approximately 6%
experience severe asthma, which
confers the most substantial impact on daily living, is associated
with an increased risk of exacerbations requiring hospitalisation,
and higher likelihood of potentially fatal asthma
attacks.1-5 In
China, 15.5% of people with asthma have experienced an exacerbation
requiring a hospital visit in the preceding 12
months.1
Kaivan Khavandi, Senior Vice President, Global Head, Respiratory
and Immunology, R&D, said: "We
are delighted with this approval, supported by evidence in a
Chinese population. Millions of people in China with severe
eosinophilic asthma can now potentially benefit from the advance in
management that Nucala could
offer - a testament to GSK's ongoing commitment to redefine
respiratory disease management globally."
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 this
condition.6 The
guidelines also reference evidence for targeted biologic therapy
that could reduce exacerbations, emergency or hospitalisation
rates, oral corticosteroid use, and also improve asthma control and
lung function.6
The approval for use in severe asthma is based on positive data
from a separate phase III
trial among Chinese patients.7,8 The
results from the Chinese study reinforce existing data for
mepolizumab in patients with severe asthma.8-13 Adverse
events were consistent with the known safety profile for
mepolizumab with no new emerging safety issues specific to Chinese
patients. 8-13 The
global clinical development programme included four key clinical
trials - DREAM9,
MENSA10,
SIRIUS11 and
MUSCA.12 These
trials established the efficacy and safety profile of mepolizumab
in patients with severe asthma with an eosinophilic phenotype with
safety data coming from pivotal, long-term and real-world
studies.9-14
The 52-week phase III trial in Chinese patients with severe asthma
studied the effect of mepolizumab relative to placebo, as add-on on
the primary endpoint of reduction in the annual rate of clinically
significant exacerbations (CSE).7,8 Patients
in the trial who received mepolizumab compared to those who
received placebo experienced 65% fewer CSE's (0.45 vs.1.31
events/year, HR [95% CI]: 0.35 [0.24, 0.50] p<0.001), had a 70%
reduction in the frequency of CSE per year requiring
hospitalisation or Emergency Department (ED) visits (RR [95% CI]
0.30 [0.12,0.77]; p=0.012), and a significantly increased period of
time before patients experienced the first CSE requiring
hospitalisation or ED visits (3.4% vs. 12.6%; HR [95% CI]: 0.26
[0.10, 0.69]; p=0.007).8
This is the second indication for mepolizumab in China, with
approval for use in adults with eosinophilic granulomatosis with
polyangiitis (EGPA) received in 2021. Epidemiological, clinical and
pathophysiological studies show that patients with EGPA usually
also have asthma, which is often severe.15
About Nucala (mepolizumab)
First approved in 2015 for severe asthma with an eosinophilic
phenotype in the US, Nucala is
the first-in-class monoclonal antibody to target
IL-5.16,17 Mepolizumab
as the first anti-IL-5 targeting biologic approved in China is
an important medical advance in the management of
asthma. IL-5
is an inflammatory signalling molecule that is central to the
development, maturation and activation of eosinophils, a type of
white blood cell implicated in the pathogenesis in the majority of
cases of severe asthma.18 Evolving
evidence suggests IL-5 has an impact on other cell types beyond
eosinophils, leading to epithelial barrier dysfunction, airways
remodelling and disease progression.19-25 Mepolizumab
binds directly to and inhibits IL-5 molecules.16,17
Nucala is
currently approved
in China for use in adults with EGPA and was included on the
National Reimbursement Drug List in January
2023. Nucala has
been studied in over 4,000 patients in 41 clinical trials across
several IL-5 mediated conditions and was the first treatment
approved in the US and Europe, across four IL-5 medicated
conditions: severe asthma with an eosinophilic phenotype, EGPA,
hypereosinophilic syndrome and chronic rhinosinusitis with nasal
polyps.16,17 Nucala has
been approved in the US, the European Union and over 25 other
markets as an add-on maintenance treatment for patients with severe
asthma.
For product and important safety information please consult the
country relevant summary of product characteristics.
EU and UK available at:
https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
US available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf
About severe 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.8-11 Severe
asthma patients can also be categorised by long-term oral
corticosteroid use. In a sub-set of severe asthma patients, type
two inflammation and over-production of eosinophils (a type of
white blood cell) leads to a range of symptoms and longer-term lung
remodelling.8-11 The
majority (more than 80%) of severe asthma patients exhibit elevated
levels of eosinophils, which act as bio-marker to facilitate
diagnosis, predict risk of exacerbations and aid evidence-based
treatment decisions.26
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.
GSK enquiries
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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, and Q3 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
1.
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.
2.
Ding B, Small M,
Wang W, et al. The disease burden of mild asthmatics in
China. European Respiratory
Journal. 2016; 48 (suppl 60): PA4208
3.
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 January 2024.]
4.
Ambrosino, N and Paggiaro, P. The management of
asthma and chronic obstructive pulmonary disease: current status
and future perspectives. Expert Rev Respir
Med. 2012;6(1):117-127.
5.
Antonicelli, L,
Bucca C, Neri M, et al. Asthma severity and medical resource
utilisation. Eur Respir
J. 2004;23(5):723-729.
6.
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 December 2023.
7.
Asthma Group of the
Chinese Thoracis Society. Guidelines for
bronchial asthma prevent and management(2020 edition) Asthma group
of Chinese Throacic Society Asthma Group, Chinese Society of
Respiratory Diseases. Guidelines for the prevention and treatment
of bronchial asthma (2020 edition)[J]. Chinese Journal of
Tuberculosis and Respiration,2020,43(12):1023-1048. Available
at: https://rs.yiigle.com/cmaid/1302286
last accessed December 2023. (China Asthma
Guideline 2020 支气管哮喘防治指南(2020年版). 中华结核和呼吸杂志, 43(12),
26.)
8.
Chen R, Wei L, Dai Y, et
al. Efficacy
and Safety of Mepolizumab as an Add-On Therapy in Chinese Patients
With Severe Eosinophilic Asthma: A Randomized, Double-Blind,
Parallel Group Phase 3 Study. Poster P620 presented at Presented at
the American Thoracic Society Meeting, Washington, DC, May 19-24,
2023. Available at: https://presentations.gsk.com/wp-content/uploads/2023/03/ATS_QR14_Chen.pdf last
accessed December 2023.
9.
Pavord ID, Korn S, Howarth P, et al.
Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre,
double-blind, placebo-controlled trial. Lancet.
2012;380(9842):651-659.
10.
Ortega, HG, Liu MC, Pavord ID, et
al. Mepolizumab Treatment
in Patients with Severe Eosinophilic
Asthma. N
Engl J Med.
2014;371(13):1198-1207.
11.
Bell, EH, Wenzel SE, Thompson PJ, et
al. Oral Glucocorticoid-Sparing Effect of Mepolizumab in
Eosinophilic Asthma. N Engl J
Med.
2014;371(130:1189-1197.
12.
Chupp GL, Bradford ES, Albers FC, 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.
13.
Flood-Page P, Swenson C, Faiferman I, et al. A
study to evaluate safety and efficacy of mepolizumab in patients
with moderate persistent asthma. Am J Respir Crit Care
Med. 2007;176(11):1062-1071.
14.
Unpublished
abstract - GSK data on file (Pavord, et al. Abstract 201956
presented at ERS 2023).
15.
Porsbjerg C, Menzies-Gow A. Co-morbidities in
severe asthma: Clinical impact and
management. Respirology. 2017;22(4):651-661.
doi:10.1111/resp.13026
16.
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 December 2023
17.
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
18.
Maspero J, Adir Y, Al-Ahmad M, et al. Type 2
inflammation in asthma and other airway
diseases. ERJ Open
Res. 2022;8(3):00576-2021.
19.
Buchheit KM, Dwyer DF,
Ordovas-Montanes J, et al. IL-5Ra marks nasal polyp IgG4-
and IgE-expressing cells in aspirin-exacerbated respiratory
disease. J Allergy
Clin Immunol. 2020;145(6):1574-1584.
20.
Buchheit KM, Lewis E, Gakpo D, et
al. Mepolizumab targets multiple
immune cells in aspirin-exacerbated respiratory
disease. J Allergy
Clin Immunol. 2021;148(2):574-584.
21.
Bajbouj K, AbuJabal R, Sahnoon L, et al. IL-5
receptor expression in lung fibroblasts: Potential role in airway
remodeling in asthma. Allergy. 2023;78(3):882-885.
22.
Barretto KT, Brockman-Schneider RA, Kuipers I, et
al. Human airway epithelial cells express a functional IL-5
receptor. Allergy. 2020;75(8):2127-2130.
23.
Varricchi G, Ferri S, Pepys J, et al. Biologics
and airway remodeling in severe asthma. Allergy. 2022;77(12):3538-3552.
24.
Santini G, Mores N, Malerba M, et al. Dupilumab
for the treatment of asthma. Expert Opin Investig
Drugs. 2017;26(3);357-366.
25.
Israel E and Reddel
HK. Severe and Difficult-to-Treat
Asthma in Adults. N Engl J
Med. 2017;377(10):965-976.
26.
Heaney LG, Perez de Llano L, Al-Ahmad M, et al.
Eosinophilic and Noneosinophilic Asthma: An Expert Consensus
Framework to Characterize Phenotypes in a Global Real-Life Severe
Asthma Cohort. Chest. 2021;160(3):814-830.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: January
10, 2024
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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