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 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: 12 December 2025, London UK
Nucala (mepolizumab)
receives positive CHMP opinion for treatment of chronic obstructive
pulmonary disease (COPD)
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Positive
opinion based on MATINEE phase III trial showing significant
reduction in COPD exacerbations versus placebo in addition to
inhaled triple therapy
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Nucala is
the only monthly biologic studied in a wide COPD population with an
eosinophilic phenotype
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Nucala could
offer a new option to millions of Europeans who remain uncontrolled
on inhaled triple therapy and have a raised blood eosinophil
count
GSK plc (LSE/NYSE: GSK) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has recommended the approval
of Nucala
(mepolizumab), a monoclonal antibody targeting interleukin-5
(IL-5), in
adults as an add-on maintenance treatment
for uncontrolled chronic obstructive pulmonary
disease (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 European Commission decision on approval is expected in Q1
2026.
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology
& Inflammation R&D, GSK said: "People
living with uncontrolled COPD with an eosinophilic phenotype
continue to experience exacerbations that can lead to irreversible
lung damage and avoidable hospitalisations and emergency department
visits. Preventing these events is crucial to slowing the
progression of disease and today's CHMP recommendation brings us
closer to providing Nucala to
patients who are in need of new options."
COPD affects more than 40 million people in Europe and more than
390 million people globally.1,2 It
is estimated that over 35% of COPD patients who are inadequately
controlled on inhaled triple therapy have a raised blood eosinophil
count (BEC) of at least 300 cells/lL.3 Recurrent
exacerbations accelerate disease progression and add to pressure on
healthcare systems through unplanned and unpredictable emergency
department visits and inpatient care.2,4 In
2021 alone, COPD had a societal cost of approximately 164 billion
euros and resulted in more than 330,000 deaths in
Europe.5
The positive opinion is based on
data from the MATINEE phase III trial in which 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).6,7 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. The
incidence of adverse events were similar between mepolizumab and
placebo (mepolizumab vs placebo: 74% vs 77%).
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).6 Mepolizumab
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.
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).6,7
MATINEE assessed the efficacy and safety of mepolizumab for 52-104
weeks, in 804 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 condition of patients
ranged in severity from moderate to very severe, or stages 2-4 as
assessed by the medically recognised scale of Global Initiative for
Chronic Obstructive Lung Disease (GOLD). 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.6
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
currently approved for use in Europe across four indications,
including severe asthma, chronic rhinosinusitis with nasal polyps
(CRSwNP), eosinophilic granulomatosis with polyangiitis (EGPA) and
hypereosinophilic syndrome (HES).8 It
was approved in the US for COPD, its fifth indication, in May
2025.
For product and important safety information please consult the
country's relevant summary of product characteristics. The EU and
UK 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 gsk.com.
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GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Sarah Clements
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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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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(London)
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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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 Q3 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. European
Respiratory Society. (2023). Introductions. https://www.ersnet.org/wp-content/uploads/2023/01/Introductions.pdf
2.
Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2026
Gold Report. Available at: goldcopd.org. Last accessed November
2025.
3.
GSK, Optum Analysis DOF (DOF 2024N562932_00).
4. Hurst
J R, et al. Susceptibility
to Exacerbation in Chronic Obstructive Pulmonary Disease. N Engl J
Med. 2010;363:1128-38.
5. International
Respiratory Coalition. Chronic obstructive pulmonary disease
(COPD). Available at:
https://international-respiratory-coalition.org/diseases/copd/.
Last accessed March 2025.
6.
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 nejm.org.
7. Pavord
ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive
Pulmonary Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI:
10.1056/NEJMoa1708208.
8.
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.
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: December
12, 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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