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 March 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: 24 March 2025, London UK
GSK's application to expand use of Nucala (mepolizumab) for the
treatment of COPD accepted for review by the European Medicines
Agency
●
Submission
based on data from MATINEE trial, which showed a statistically
significant and clinically meaningful reduction in the annualised
rate of moderate/severe exacerbations with mepolizumab versus
placebo
●
Nucala (mepolizumab) could
be the first biologic with monthly dosing for patients with COPD,
if approved
●
More
than 40 million people in Europe live with COPD, one of the leading
causes of hospitalisation and death
GSK plc (LSE/NYSE: GSK) today announced
that the
European Medicines Agency (EMA) has accepted for review its
application to expand the use of Nucala (mepolizumab), a
monoclonal antibody that targets interleukin-5
(IL-5), as
an add-on maintenance treatment for patients with chronic
obstructive pulmonary disease (COPD) with an eosinophilic
phenotype.
The application is supported by results from the positive phase III
MATINEE trial, which showed a statistically significant and
clinically meaningful reduction in the annualised rate of
moderate/severe exacerbations with mepolizumab compared to
placebo.[1] The
trial recruited patients across a wide spectrum of COPD phenotypes
and clinical presentations. These data indicate that mepolizumab,
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. Results of MATINEE will be
presented at a future scientific congress.
IL-5 is a key cytokine (protein) in type 2 inflammation which is an
underlying driver in many diseases.[2],[3],[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[5] and
over 40 million people in Europe[6].
It is one of the leading causes of hospitalisation in many
countries[7].
In 2021 alone, COPD had a societal cost of approximately 164
billion euros and resulted in more than 330,000 deaths in
Europe.6 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.5,[8]
If approved, mepolizumab could be the first biologic with monthly
dosing for patients with COPD.
Mepolizumab is
currently approved for use in Europe across four IL-5 mediated
conditions. These
include two respiratory indications as an add-on treatment for
severe refractory eosinophilic asthma in adults, adolescents and
children aged 6 years and older and as an add-on therapy with
intranasal corticosteroids for the treatment of adult patients with
severe 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 mepolizumab as
an add-on treatment for patients aged 6 years and older with
relapsing-remitting or refractory eosinophilic granulomatosis with
polyangiitis (EGPA) and as an add-on treatment for adult patients
with inadequately controlled hypereosinophilic syndrome without an
identifiable non-haematologic secondary cause.[9]
Mepolizumab is
currently not approved for use in COPD in any
country.
About the Nucala (mepolizumab) 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. Mepolizumab has
been developed for the treatment of a range of IL-5 mediated
diseases associated with type 2 inflammation.
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 mepolizumab and
support future submissions and approvals for use in this
indication.[10]
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.1
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.5 Type
2 inflammation is present in a variety of immuno-inflammatory
conditions and is a major contributor to symptoms and exacerbations
in up to 40% of people with COPD.[11] 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
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. Exacerbations are acute episodes of worsening
COPD symptoms and can result in hospitalisation and irreversible
lung damage that leads to progressive lung function decline. 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. Early intervention is
important in preventing exacerbations and cumulative lung
damage.5
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. 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. 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
2024.
Registered in England & Wales:
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3888792
Registered Office:
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New Oxford Street
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WC1A
1DG
[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 March 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] Global
Initiative for Chronic Obstructive Lung Disease. 2024 Gold Report.
Available at: https://goldcopd.org/2024-gold-report/.
Last accessed March 2025.
[6] International
Respiratory Coalition. Chronic
obstructive pulmonary disease (COPD). Available
at: https://international-respiratory-coalition.org/diseases/copd/.
Last accessed March 2025.
[7] The
Health Policy Partnership. The state of COPD. Available
at: https://www.healthpolicypartnership.com/project/the-state-of-copd/.
Last accessed March 2025.
[8] Hurst
J R, et al. Susceptibility to Exacerbation in Chronic Obstructive
Pulmonary Disease. N Engl J Med.
2010;363:1128-38.
[9] European
Medicines Authority. Nucala prescribing information. Available
at: https://www.ema.europa.eu/en/documents/product-information/nucala-epar-product-information_en.pdf.
Last accessed March 2025.
[10] 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.
[11] 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.
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: March
24, 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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