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 February 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(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: 20 February 2025, London UK
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.
About the Nucala development programme for
COPD
First approved in 2015 for severe asthma with an eosinophilic
phenotype in the US, mepolizumab is a monoclonal antibody that
targets and binds to interleukin-5 (IL-5), a key messenger protein
(cytokine) in type 2 inflammation.8 Nucala has
been developed for the treatment of a range of IL-5 mediated
diseases associated with type 2 inflammation.8
The mepolizumab programme in COPD is comprised of three clinical
trials. The first two studies, METREX and METREO, completed in
2017. MATINEE was designed to supplement METREX and METREO,
building on our learnings from these studies and IL-5 science to
identify the patients who could benefit the most
from Nucala and support future submissions and approvals
for use in this indication.9
MATINEE is a phase 3, randomized (1:1), double-blind,
parallel-group trial assessing the efficacy and safety of
mepolizumab 100 mg as add-on therapy, administered subcutaneously
every 4 weeks for 52-104 weeks, versus placebo in addition to
inhaled triple therapy (dual long-acting bronchodilators plus
inhaled corticosteroid) in 804 patients with COPD, a history of
exacerbations, and evidence
of type 2 inflammation characterised by raised blood eosinophil
count.1
The primary
endpoint was met with the addition of Nucala to
inhaled maintenance therapy, showing a statistically
significant and clinically meaningful reduction in the annualised
rate of moderate/severe exacerbations versus
placebo with patients treated for
52-104 weeks.
Data from MATINEE will be presented at a future scientific congress
or in a peer reviewed journal. Global regulatory submissions
including MATINEE data are ongoing.
For product and important safety information please consult the
country relevant summary of product characteristics. European
information available at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf
About chronic obstructive pulmonary disease
(COPD) and
type 2 inflammation
COPD is a progressive and heterogeneous inflammatory lung disease
that includes chronic bronchitis and/or emphysema. It affects more
than 390 million people globally and is the third leading cause of
death resulting in more than 3 million deaths
annually.5,10 Patients
with COPD experience persistent respiratory symptoms such as
breathlessness, cough, and sputum along with progressive airflow
obstruction due to the chronic inflammation that impact daily
life.10
Exacerbations are acute episodes of worsening COPD symptoms and can
result in hospitalisation and irreversible lung damage that leads
to progressive lung function decline.10-12 Recurrent
exacerbations accelerate disease progression and further increase
the risk of hospitalisation adding to pressures on healthcare
systems through emergency department visits and inpatient
care.10-12 For
patients this can result in a vicious cycle of deterioration in
overall physical health, which leads to worsening of symptoms and
quality of life, and increased mortality.10-12
Despite inhaled triple therapy, many patients experience persistent
symptoms and exacerbations meaning there is a need for targeted
therapies to address the underlying pathophysiology linked to
disease progression.10-13 Permanent
and irreversible tissue damage seen in patients with advanced
disease make it challenging to provide further improvements in
respiratory symptoms and quality of life and is the reason why
early intervention is so important in preventing exacerbations and
cumulative lung damage.10
There is evidence to show IL-5 has broad effects on other
structural and immune and cell types beyond eosinophils, and how
they contribute to inflammation, which can lead to lung remodelling
and disease progression.2,3,14-18 Ongoing
research is generating further evidence to understand the roles of
these cells and their potential contribution to clinical outcomes
in patients with respiratory diseases. Type 2 inflammation drives
the underlying dysfunction of various immune-mediated conditions.
IL-5 is a key cytokine (protein) in type 2
inflammation.2-4 The
presence of type 2 inflammation can be detected by blood eosinophil
count, which measures the level of a type of white blood
cell.2-4
About GSK in respiratory
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.
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.
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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 GSK's Annual Report on Form 20-F for 2023, and
GSK's Q4 Results for 2024.
Registered in England & Wales:
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WC1A
1DG
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/news-room/feature-stories/detail/advancing-copd-care-in-china-through-a-comprehensive-approach#:~:text=China%20has%20almost%20100%20million%20people%20living%20with,for%20more%20than%200.9%20million%20deaths%20in%202013.
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.
8. Nucala US
information available at: https://www.accessdata.fda.gov/drugsatda_docs/label/2017/125526s004lbl.pdf last
accessed February 2025
9.
Pavord ID, et al. Mepolizumab for Eosinophil-Associated COPD:
Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis.
2021 Jun 16;16:1755-1770.
10. The
Global Strategy for Diagnosis, Management and Prevention of COPD
2024. Available at: www.goldcopd.org Last
accessed: November 2024.
11. Hurst
J R, et al. Susceptibility
to Exacerbation in Chronic Obstructive Pulmonary
Disease. N Engl J
Med.
2010;363:1128-38.
12. Whittaker
H, et al. Frequency
and Severity of Exacerbations of COPD Associated with Future Risk
of Exacerbations and Mortality: A UK Routine Health Care Data
Study. Int J Chron
Obstruct Pulmon Dis.
2022;17:427-437.
13. Rabe
KF, et al. Targeting Type 2 Inflammation and Epithelial Alarmins in
Chronic Obstructive Pulmonary Disease: A Biologics
Outlook. Am J Respir
Crit Care Med. 2023;208(4):395-405.
14. Buchheit
KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J
Allergy Clin Immunol.
2021;148(2):574-584.
15. Barretto
KT, et al. Human airway epithelial cells express a functional IL-5
receptor. Allergy.
2020;75(8):2127-2130.
16. Bajbouj
K, et al. IL-5 receptor expression in lung fibroblasts: Potential
role in airway remodelling in asthma. Allergy.
2023;78(3):882-885.
17. Siddiqui
S, et al. Eosinophils and tissue remodeling: Relevance to airway
disease. J
Allergy Clin Immunol.
2023;152(4):841-857.
18. Bergantini
L, et al. Regulatory T cell monitoring in severe eosinophilic
asthma patients treated with mepolizumab. Scand
J Immunol.
2021;94(1):e13031.
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: February
20, 2025
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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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