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 May 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: 22 May 2025, London UK
Nucala (mepolizumab)
approved by US FDA for use in adults with chronic obstructive
pulmonary disease (COPD)
●
Nucala is
the only approved biologic studied in a wide COPD population with
an eosinophilic phenotype characterised by blood
eosinophil count (BEC) starting at 150
cells/lL
● Approval based on the positive MATINEE and METREX
phase III trials
● MATINEE data included reduction of exacerbations
leading to hospitalisation and/or emergency department visits
● Nearly 70% of patients in the US
who are inadequately controlled on inhaled triple therapy have a
BEC ≥150
cells/lL
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Nucala (mepolizumab) as an add-on maintenance
treatment for adult patients with inadequately controlled COPD and
an eosinophilic phenotype.
FDA's approval was based on data from the positive MATINEE and
METREX phase III trials. Across these trials, mepolizumab showed a
clinically meaningful and statistically significant reduction in
the annualised rate of moderate/severe exacerbations versus placebo
in a wide spectrum of COPD patients with an eosinophilic
phenotype.1,2 Preventing
exacerbations is a key goal of COPD management.3 Exacerbations
are devastating for patients, known to cause irreversible lung
damage, worsening of symptoms and increased
mortality.3 The
incidence of adverse events was similar between placebo and
mepolizumab groups.1,2
Mepolizumab is the only approved biologic evaluated in patients
with an eosinophilic phenotype characterised by a blood eosinophil
count (BEC) threshold as low as ≥150
cells/µL.1,2 BEC
is captured by a simple blood test that measures levels of
eosinophils, a type of white blood cell which is a biomarker for
type 2 inflammation and indicates a patient's risk of
exacerbation.3 Approximately
70% of COPD patients in the US who are inadequately controlled on
inhaled triple therapy and continue to exacerbate have a BEC
starting at 150 cells/lL and above.4,5 This
represents over a million people at risk of exacerbations,
including those leading to emergency department (ED) visits and/or
hospitalisations, who could add mepolizumab as an option to their
COPD treatment.4,5
Kaivan Khavandi, SVP, Global Head, Respiratory, Immunology &
Inflammation R&D, GSK, said: "The approval
of Nucala in
the US provides an important option for COPD patients. Long-term
follow-up studies have demonstrated that exacerbations are the
single most important predictor of future risk, with particularly
poor outcomes in those requiring hospital visits or admissions.
Today there is hope for improved care for COPD patients with an
eosinophilic phenotype, including those with a BEC threshold as low
as ≥150cells/lL who need new options like Nucala to support
their treatment journey."
Jean Wright, MD, MBA, Chief Executive Officer of
the COPD Foundation said: "COPD
isn't just a disease, it's a relentless cycle. For individuals
living with COPD, managing exacerbations is an ongoing challenge,
even with inhaled maintenance therapy. Biologics like
mepolizumab are
providing renewed optimism for those affected by
COPD."
In both MATINEE and METREX trials, mepolizumab demonstrated a
statistically significant reduction in the annualised rate of
moderate or severe exacerbations compared with placebo, in patients
with an eosinophilic phenotype, when added to triple inhaled
therapy (MATINEE: rate ratio [RR], 0.79; 95% confidence interval
[CI], 0.66 to 0.94; p=0.01) (METREX: rate ratio, 0.82; 95% CI, 0.68
to 0.98; adjusted p=0.04).1,2 In
a pre-defined secondary endpoint in MATINEE, the annualised rate of
COPD exacerbations requiring ED visits and/or hospitalisation was
reduced in the mepolizumab group when compared with placebo (rate
ratio [RR] of 0.65; 95% CI: 0.43, 0.96 [not statistically
significant due to a failure of an endpoint higher in the
pre-defined testing hierarchy]).1 COPD-related
hospitalisations are a major healthcare challenge and are projected
to become the number one cause of medical
admissions.6 Emergency
department visits and inpatient care already account for a large
proportion of the annual direct medical costs of COPD, costing the
US healthcare system around $7 billion a year.7
Mepolizumab is currently not approved for use in COPD in any other
country. Regulatory submissions are under review in China and
Europe.
About MATINEE and METREX
Both MATINEE and METREX are phase III, randomised (1:1),
double-blind, parallel-group trials 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).1,2
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
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.1
The full study results from MATINEE were recently published in
the New
England Journal of Medicine1 with
further data presented at the 2025 American Thoracic Society
International Congress, including additional sub-analyses
in patients with or without cardiovascular comorbidities,
varying severities of prior exacerbations, and those with chronic
bronchitis, emphysema-only or both.1
In METREX, the efficacy and safety of mepolizumab was evaluated for
52 weeks in 836 patients randomised (1:1) to mepolizumab or placebo
across two groups, the eosinophilic phenotype group (blood
eosinophil count of ≥150 cells/µl at study entry or
≥ 300 cells/µl within the past year) or the
non-eosinophilic phenotype group (blood eosinophil count of <150
cells/µl at study entry and no evidence of ≥300
cells/µl within the past year).
The study results from METREX were published in 2017
in the
New England Journal of Medicine.2
About COPD
COPD is a progressive and heterogeneous inflammatory lung disease
that includes chronic bronchitis and/or
emphysema.3 It
affects more than 390 million people globally and is the third
leading cause of death.8,9 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.3
Despite inhaled triple therapy, many patients experience persistent
symptoms and exacerbations.10 Exacerbations
are acute episodes of worsening COPD symptoms, which can result in
hospitalisation and irreversible lung damage.3 Early
intervention is important in preventing exacerbations and
cumulative lung damage.3
About Nucala
Nucala 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. It is currently approved for use in Europe across
four IL-5 mediated conditions and in the US across five such
conditions.
The US Prescribing Information is available
at NUCALA-PI-PIL-IFU-COMBINED.PDF11
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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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 Q1 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/full/10.1056/NEJMoa2413181. Last
accessed May 2025
2.
Pavord ID, et al. Mepolizumab for
Eosinophilic Chronic Obstructive Pulmonary
Disease. N Engl J
Med. Oct
2017;377:1613-1629. DOI: 10.1056/NEJMoa1708208.
3. Global
Initiative for Chronic Obstructive Lung Disease (GOLD). 2025 Gold
Report. Available at: goldcopd.org.
Last accessed May 2025.
4.
GSK, Optum Analysis DOF (DOF 2024N562932_00).
5.
Müllerová H, et
al. Exacerbations
and health care resource use among patients with COPD in relation
to blood eosinophil counts. Int J Chron
Obstruct Pulmon Dis. 2019;14:683-692.
DOI: 10.2147/COPD.S194367.
6.
Khakban A, et
al. The
Projected Epidemic of Chronic Obstructive Pulmonary Disease
Hospitalizations over the Next 15 Years. A Population-based
Perspective. Am J Respir
Crit Care Med.
2017;195(3):287-291. DOI: 10.1164/rccm.201606-1162PP.
7. American
Lung Association (ALA). COPD Trends Brief - Burden. Available
at: Lung.org.
Last accessed: May 2025.
8. Adeloye D,
et al. 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;10(5):447-458. DOI: 10.1016/S2213-2600(21)00511-7.
9. 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.
10. Chen S, Miravitlles M,
Rhee CK, et al. Patients with Chronic Obstructive Pulmonary Disease
and Evidence of Eosinophilic Inflammation Experience Exacerbations
Despite Receiving Maximal Inhaled Maintenance Therapy. Int J Chron
Obstruct Pulmon Dis. 2022 Sep 9;17:2187-2200.
DOI: 10.2147/COPD.S378649.
11. Food and Drug Administration.
Nucala Full Prescribing Information. Available
at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Nucala/pdf/NUCALA-PI-PIL-IFU-COMBINED.PDF
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: May
23, 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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