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 2026
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: 6 February 2026, London UK
Nucala (mepolizumab)
approved by the European Commission for the treatment of chronic
obstructive pulmonary disease (COPD)
●
Approval
based on results from MATINEE showing significant reduction in the
rate of moderate/severe exacerbations versus placebo
●
Nucala is
the first and only monthly biologic in the EU evaluated in a wide
COPD population with an eosinophilic phenotype
●
MATINEE
data showed a reduction in exacerbations leading to emergency
department visits and/or hospitalisations versus
placebo
GSK plc (LSE/NYSE: GSK) today announced the European Commission
has approved Nucala (mepolizumab), a
monoclonal antibody targeting interleukin-5 (IL-5), in adults as an
add-on maintenance treatment for uncontrolled COPD characterised by
raised blood eosinophils on a combination of an inhaled
corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a
long-acting muscarinic antagonist (LAMA).
The approval was based on data from the positive MATINEE phase III
trial in which mepolizumab showed a clinically meaningful and
statistically significant reduction in the annualised rate of
moderate/severe exacerbations versus placebo plus standard of care
in a wide spectrum of COPD patients with an eosinophilic
phenotype.1
COPD affects over 390 million people, including about 40 million in
Europe.2,3 Globally,
it is projected to be the leading cause of hospital admissions over
the next decade.4 If
hospitalised due to COPD, one in ten patients will die during the
stay, up to one in four over the next year and half will lose their
lives within five years.5,6 Nucala is
the first biologic with pre-specified phase III data showing a
reduction in the annualised rate of exacerbations leading to
emergency department visits and/or hospitalisation versus
placebo.1
Kaivan Khavandi, SVP, Global Head, Respiratory,
Immunology & Inflammation R&D, GSK,
said: "For
the first time, adults with uncontrolled COPD characterised by
raised blood eosinophils in the EU will have the option for a
monthly biologic
shown to significantly reduce exacerbations, which can lead to
irreversible lung damage, hospitalisations and emergency department
visits. Nucala could
offer relief to the millions of Europeans who need additional
options beyond inhaled triple therapy to manage their
COPD."
Susanna Palkonen, Director, European Federation of Allergy and
Airways Diseases Patients' Associations (EFA),
said: "The
burden for patients living with COPD is immense, especially for
those facing continued exacerbations and repeated hospitalisations.
We welcome, and our community celebrates, new treatment options for
COPD patients as they are desperately needed."
In MATINEE, mepolizumab demonstrated a statistically significant
reduction in the annualised rate of moderate or severe
exacerbations compared with placebo, both in addition to inhaled
triple therapy [rate ratio 0.79, 95% confidence interval (0.66,
0.94), P=0.01] (AER mepolizumab = 0.80 exacerbations per year
versus placebo = 1.01).1 The
MATINEE trial studied mepolizumab in a wide spectrum of patients
with an eosinophilic phenotype including chronic bronchitis,
emphysema only or a combination of both.
In a pre-defined secondary endpoint, the annualised rate of COPD
exacerbations requiring ED visits and/or hospitalisation was
reduced in the mepolizumab group when compared with placebo [rate
ratio 0.65; 95% CI (0.43, 0.96) nominally significant after
adjustment for multiplicity] (AER mepolizumab = 0.13 exacerbations
per year versus placebo = 0.20).1 The
incidence of adverse events were similar between mepolizumab and
placebo (mepolizumab vs placebo: 74% vs 77%). The
full results from the MATINEE phase III trial were published
in The
New England Journal of Medicine in
April 2025 with further data presented at the 2025 American
Thoracic Society International Congress.1
In addition to COPD, Nucala is
approved in Europe across four other diseases driven by underlying
type 2 inflammation, including severe
asthma, chronic rhinosinusitis with nasal polyps (CRSwNP),
eosinophilic granulomatosis with polyangiitis (EGPA), and
hypereosinophilic syndrome (HES). It has also been approved for
COPD in the US, UK, and China.
About COPD
COPD is a progressive and heterogeneous
inflammatory lung disease that includes chronic bronchitis and/or
emphysema.2 It
affects more than 390 million people globally and is the third
leading cause of death.2,7 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.2
Despite inhaled triple therapy, many patients experience persistent
symptoms and exacerbations.8 A
proportion of these patients have elevated type 2 inflammation,
characterised by raised BEC. This inflammation contributes to the higher
risk of exacerbations, or acute episodes of worsening COPD
symptoms, which can result in hospitalisation and irreversible lung
damage.2 Early
intervention is important in preventing exacerbations and
cumulative lung damage.2
About MATINEE
MATINEE is a phase III, randomised (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 versus placebo in addition to optimal inhaled triple
therapy (dual long-acting bronchodilators plus inhaled
corticosteroid).1,8 MATINEE
assessed the efficacy and safety of mepolizumab in patients with
COPD with evidence of type 2 inflammation, characterised by a
raised blood eosinophil count (≥300 cells/µL). Patients
could participate with a range of clinical presentations of COPD
including chronic bronchitis, emphysema only or a combination of
both. The full analysis of MATINEE included 403 patients enrolled
on the mepolizumab arm and 401 on placebo, all of whom had
experienced exacerbations in the previous year despite receiving
optimised inhaled maintenance therapy.1
About Nucala (mepolizumab)
Nucala is a monoclonal
antibody that targets and binds to IL-5. Nucala has been developed for the treatment of a
range of diseases with underlying type 2
inflammation. Nucala is approved for use in Europe across five
indications, including severe asthma, CRSwNP, EGPA, HES and
COPD.9
For product and important safety information please
consult the country's relevant summary of product
characteristics. The EU Prescribing Information is available
at: NUCALA-EPAR-PRODUCT-INFORMATION_EN.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, GSK is 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 of modifying the underlying disease dysfunction
and preventing 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 www.gsk.com.
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Media:
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Sarah Clements
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Kathleen Quinn
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Constantin Fest
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+44 (0) 7831 826525
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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Steph Mountifield
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+44 (0) 7796 707505
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Sam Piper
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+44 (0) 7824 525779
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 3126
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(Philadelphia)
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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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q4 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1 Sciurba F, et al. Mepolizumab to prevent exacerbations in COPD
with an eosinophilic phenotype. N Engl J Med. Apr
2025;392:1710-1720. Available at https://www.nejm.org/doi/10.1056/NEJMoa2413181
2 Global Initiative for Chronic Obstructive Lung Disease (GOLD).
2026 Gold Report. Available at: https://goldcopd.org/2026-gold-report-and-pocket-guide/.
Last accessed November 2025.
3 European Respiratory Society. (2023).
Introductions. https://www.ersnet.org/wp-content/uploads/2023/01/Introductions.pdf
4 Khakban, Amir et al. "The Projected Epidemic of Chronic
Obstructive Pulmonary Disease Hospitalizations over the Next 15
Years. A Population-based Perspective." American journal of
respiratory and critical care medicine vol. 195,3 (2017): 287-291.
doi:10.1164/rccm.201606-1162PP. Accessed April 2025.
5 Waeijen-Smit
K, et al. Global mortality and readmission rates following COPD
exacerbation-related hospitalisation: a meta-analysis of
65 945 individual patients. ERJ Open Res. 2024 Feb
26;10(1):00838-2023. doi:
doi.org/10.1183/23120541.00838-2023
6 van Hirtum PV, et al. Long term survival after admission for COPD
exacerbation: A comparison with the general population. Respir Med.
2018;137:77-82. doi:10.1016/j.rmed.2018.02.015
7 Chen S, et al. The global economic burden of chronic obstructive
pulmonary disease for 204 countries and territories in 2020-50: a
health-augmented macroeconomic modelling study. Lancet Glob Health.
2023;11(8):e1183-e1193. DOI:
10.1016/S2214-109X(23)00217-6.
8 Pavord ID, et al. Mepolizumab
for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J
Med. Oct 2017;377:1613-1629. DOI:
10.1056/NEJMoa1708208.
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 January 2026.
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
06, 2026
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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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