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 December 2024
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: 09 December 2024 London UK
US FDA accepts GSK's submission for
the use of Nucala (mepolizumab) in COPD
●
Submission
supported by MATINEE data showing significant and clinically
meaningful reduction in annualised rate of moderate/severe
exacerbations compared with placebo
●
Nucala could
be the first approved biologic with monthly dosing for patients
with COPD
●
COPD
affects more than 14 million people in the US with estimates of
500,000 hospitalisations and up to 1.3 million emergency department
visits each year
GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug
Administration (FDA) has accepted for review, data from the MATINEE
study to support the regulatory review process to obtain a new
indication for the use of Nucala (mepolizumab), as an add-on maintenance
treatment for patients with chronic obstructive pulmonary disease
(COPD) with an eosinophilic phenotype. The Prescription Drug User Fee Act (PDUFA) date is 7
May 2025.
The submission is based on data from the MATINEE study, which
evaluated the efficacy and safety of mepolizumab in 804 patients
with COPD who have evidence of type 2 inflammation characterised by
blood eosinophil count.1 The
trial recruited COPD patients with broad clinical presentations
including hard to treat patients with emphysema-only, chronic
bronchitis only, or a mix of both. The MATINEE study met
its primary
endpoint with the addition of mepolizumab to inhaled maintenance
therapy, achieving a statistically
significant and clinically meaningful reduction in the annualised
rate of moderate/severe exacerbations versus
placebo with patients treated for
52-104 weeks.
IL-5 is a key cytokine (protein) in type 2
inflammation, an
inflammatory process exhibited in up to 40% of patients with COPD
and the underlying pathobiology that drives symptoms and
exacerbations.2-4 Type
2 inflammation is typically
detected by blood eosinophil count, a biomarker, which can be
measured by a simple blood test. This test can help indicate a COPD
patient's risk of exacerbation and deterioration, their response to
treatment, and inform treatment strategies in these
patients.5
COPD affects more than 390 million people globally and
over 14
million people
in the US, exerting a significant burden on healthcare resources
and the lives of patients.6-9 Recurrent
exacerbations add to pressures on healthcare systems
and account
for a large proportion of the annual direct medical costs of
COPD with
emergency department visits and inpatient care costing the US
healthcare system around $7 billion a year.6,8,9
The full results of MATINEE will be presented at a future
scientific congress and form the basis of regulatory submissions
around the world.
Nucala is
currently approved for use in the US across four IL-5 mediated
conditions. These include two respiratory indications as an
add-on maintenance treatment for patients with severe asthma with
an eosinophilic phenotype aged 6 years and older and as an add-on
maintenance treatment for adult patients with chronic
rhinosinusitis with nasal polyps (CRSwNP) and inadequate response
to nasal corticosteroids. Indications also include the use
of Nucala for
the treatment of adult patients with eosinophilic granulomatosis
with polyangiitis (EGPA) and for the treatment of patients ages 12
years and older with hypereosinophilic syndrome (HES) for ≥6
months without an identifiable non-hematologic secondary
cause.12 Nucala is
currently not indicated for COPD anywhere in the
world.
About chronic obstructive pulmonary disease
(COPD) and
type 2 inflammation
COPD is a progressive and heterogenous inflammatory lung disease
that includes chronic bronchitis and emphysema, and is the third
leading cause of death resulting in more than 3 million deaths
annually.5,7 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.5 Exacerbations
are acute episodes of worsening COPD symptoms and can result in
hospitalisation and irreversible lung damage that leads to
progressive lung function decline. Exacerbations can result
in a cycle of deterioration in overall physical health and
increased mortality.5,12 Many
patients experience persistent symptoms and exacerbations meaning
there is a need for targeted therapies to address the underlying
pathophysiology linked to disease progression.5,13-15
Type 2 inflammation is present in a variety of immuno-inflammatory
conditions and is the underlying pathology that drives symptoms and
exacerbations in up to 40% of people with COPD. 2 Blood
eosinophil count is a biomarker for type 2 inflammation that can be
easily measured by a simple blood test for levels of a type of
white blood cell called eosinophils. IL-5
is a core cytokine (protein) in type 2
inflammation alongside
IL-4 and IL-13.2 IL-5
is responsible for the growth, activity, and survival of
eosinophils and there is now evidence to show IL-5 has broad
effects on other immune and structural cell types beyond
eosinophils, including those that contribute to inflammation, lung
remodelling and disease progression.2,15-20 The
individual role of these cell types has not been definitively
established in COPD.
About Nucala
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. Nucala has been developed for the treatment of a
range of IL-5 mediated diseases associated with type 2
inflammation.
About the mepolizumab development programme for COPD
The mepolizumab program 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.21
For product and important safety information please consult the
country relevant summary of product
characteristics.
US information available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf
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.
|
GSK enquiries
|
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Dan
Smith / Sarah Clements
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
Alison
Hunt
|
+1 540 742 3391
|
(Washington
DC)
|
|
|
|
|
|
|
Investor
Relations:
|
Annabel
Brownrigg-Gleeson
|
+44 (0)
7901 101944
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
|
Camilla
Campbell
|
+44 (0)
7803 050238
|
(London)
|
|
|
Steph
Mountifield
|
+44 (0)
7796 707505
|
(London)
|
|
|
Jeff
McLaughlin
|
+1 215
751 7002
|
(Philadelphia)
|
|
|
Frannie
DeFranco
|
+1 215
751 4855
|
(Philadelphia)
|
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 Q3 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1.
ClinicalTrials.gov. Mepolizumab as Add-on Treatment IN Participants
With COPD Characterized by Frequent Exacerbations and Eosinophil
Level (MATINEE) Available at: https://clinicaltrials.gov/study/NCT04133909. Last
accessed November 2024.
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. GOLD
Science Committee Members (2023-2024). The Global Strategy for
Diagnosis, Management and Prevention of CO 2024. Available
at: www.goldcopd.org Last
accessed: November 2024.
6. 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.
7. Boers E, et al. Global
Burden of Chronic Obstructive Pulmonary Disease Through
2050. JAMA
Netw Open.
2023;6(12).
8. CDC.
Trends in the Prevalence of Chronic Obstructive Pulmonary Disease
Among Adults Aged ≥18 Years - United States, 2011-2021.
Weekly / November 17, 2023 / 72(46);1250-1256. Available
at; Trends
in the Prevalence of Chronic Obstructive Pulmonary Disease Among
Adults Aged ≥18 Years - United States, 2011-2021 | MMWR
(cdc.gov) Last
accessed: November 2024.
9. American Lung
Association. COPD Trends Brief - Burden. Available
at: https://www.lung.org/research/trends-in-lung-disease/copd-trends-brief/copd-burden Last
accessed: November 2024.
10. Press
VG, et al. Preventing COPD Readmissions Under the Hospital
Readmissions Reduction Program: How Far Have We
Come? Chest.
2021;159(3):996-1006.
11. Ruan,
H, et al. Readmission rate for acute exacerbation of chronic
obstructive pulmonary disease: A systematic review and
meta-analysis. Respir.
Med. 2023, 206,
107090.
12. 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 November 2024.
13. Hurst
J R, et al. Susceptibility
to Exacerbation in Chronic Obstructive Pulmonary
Disease. N Engl J
Med.
2010;363:1128-38.
14. 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.
15. 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.
16. Buchheit
KM, et al. Mepolizumab targets multiple immune cells in
aspirin-exacerbated respiratory disease. J
Allergy Clin Immunol.
2021;148(2):574-584.
17. Barretto
KT, et al. Human airway epithelial cells express a functional IL-5
receptor. Allergy.
2020;75(8):2127-2130.
18. Bajbouj
K, et al. IL-5 receptor expression in lung fibroblasts: Potential
role in airway remodelling in asthma. Allergy.
2023;78(3):882-885.
19. Siddiqui
S, et al. Eosinophils and tissue remodeling: Relevance to airway
disease. J
Allergy Clin Immunol.
2023;152(4):841-857.
20. Bergantini
L, et al. Regulatory T cell monitoring in severe eosinophilic
asthma patients treated with mepolizumab. Scand
J Immunol.
2021;94(1):e13031.
21.
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.
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.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: December
09, 2024
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
Von Dez 2024 bis Jan 2025
GSK (PK) (USOTC:GLAXF)
Historical Stock Chart
Von Jan 2024 bis Jan 2025
