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: 15 December 2025, London UK
Exdensur (depemokimab)
approved in the UK for treatment
of asthma with type 2 inflammation and chronic rhinosinusitis with
nasal polyps
● First and only ultra-long-acting biologic with
twice-yearly dosing to treat respiratory
diseases
●
UK
approval based on data from the SWIFT and ANCHOR phase III
trials
●
Exdensur has
shown sustained efficacy to reduce exacerbations, with fewer
hospitalisations
●
First global approval for Exdensur,
with upcoming regulatory decisions
expected in
the US, Japan, EU and China
GSK plc (LSE/NYSE: GSK) today announced
the marketing authorisation of Exdensur (depemokimab) by
the UK's Medicines and Healthcare products Regulatory Agency
(MHRA). In the UK, Exdensur is
now approved in two
indications:
● as an add-on maintenance treatment of
asthma in adult and adolescent patients aged 12 years and older
with type 2 inflammation characterised by an eosinophilic phenotype
who are inadequately controlled on maximum moderate-dose or
high-dose inhaled corticosteroids (ICS) plus another asthma
controller;
●
as an
add-on therapy with intranasal corticosteroids for the treatment of
adult patients with severe chronic rhinosinusitis with nasal polyps
(CRSwNP) for whom therapy with systemic corticosteroids and/or
surgery do not provide adequate control.
The approval is based on data from the SWIFT and ANCHOR phase III
trials which showed sustained
efficacy with a twice-yearly dosing regimen for
depemokimab. Each
of the four trials met their primary or co-primary endpoints with
statistically significant and clinically meaningful results,
comparing the addition of depemokimab to standard of care versus
standard of care alone.1,2
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology
& Inflammation R&D, GSK said: "Today's
UK approval of Exdensur,
the first in the world, has the potential to redefine care for
millions of patients. This ultra-long-acting biologic delivers
sustained efficacy to reduce asthma exacerbations, keep patients
out of hospital and help prevent cumulative lung damage in just two
doses a year. This is a step change in respiratory treatment, and
we look forward to additional regulatory decisions expected in the
US, Japan, EU and China."
Asthma affects more than 260 million people
globally3 and about
7 million people in the UK,4 a
portion of whom have type 2 inflammation characterised by an
eosinophilic phenotype.5 Approximately half
continue to experience symptoms and exacerbations despite
treatment.6 Asthma
exacerbations place a significant resource burden on healthcare
systems due to emergency department visits and hospitalisations,
with an estimated 22% increase in NHS costs by
2031.7 With
the potential to reduce asthma exacerbations, including those
leading to hospitalisations, and alleviate the debilitating
symptoms associated with CRSwNP, Exdensur could
improve patient outcomes while contributing to a reduction in
health system burden.
The pooled results from the SWIFT trials showed a 54% reduction in
clinically significant exacerbations (asthma attacks) over 52 weeks
[rate ratio 0.46, 95% confidence interval (0.36, 0.59), nominal
p<0.001] (AER depemokimab = 0.51 exacerbations per year versus
placebo = 1.11).1
Additionally, this pooled
analysis showed
a 72% reduction [RR 0.28, 95% CI (0.13, 0.61), nominal p=0.002]
(AER: depemokimab = 0.02 versus placebo = 0.09) in the secondary
endpoint of clinically significant exacerbations requiring
hospitalisation or emergency department visit compared to
placebo.1 In
AGILE, an open-label 12-month extension study, depemokimab
maintained the results seen in SWIFT-1 and SWIFT-2, confirming the
sustained safety and efficacy of a twice-yearly dose of depemokimab
over the course of two years.
Pooled results from the ANCHOR trials showed an improvement
(reduction) from baseline in nasal polyp score (scale: 0-8) at 52
weeks [treatment difference -0.7, 95% CI (-0.9, -0.4), nominal
p<0.001] and
in nasal obstruction verbal response scale (scale: 0-3) over weeks
49-52 [treatment difference -0.24, 95% CI (-0.39, -0.08), nominal
p=0.003].2
Across these trials, depemokimab was well-tolerated, with patients
experiencing a similar rate and severity of side effects as those
receiving placebo.1,2
Depemokimab recently received a positive CHMP opinion in the EU and
it is currently under regulatory review in other countries,
including in the US, Japan and China. Decisions on these approvals
are expected starting in December 2025 and continuing through H1
2026.
About asthma with type 2 inflammation
Asthma
affects more than 260 million people globally, many of whom
continue to experience symptoms and exacerbations despite
treatment.8,9 Severe asthma
is defined as asthma that requires treatment with medium- to
high-dose inhaled corticosteroids plus a second therapy (i.e.,
systemic corticosteroid or biologic) to prevent it from becoming
uncontrolled, or which remains uncontrolled despite
therapy.10Type 2 inflammation
is the underlying cause of pathology in more than 80% of patients
with severe asthma, in which patients exhibit elevated levels of
eosinophils (a type of white blood cell).11
About CRSwNP
CRSwNP is caused by inflammation of the nasal lining that can lead
to soft tissue growths, known as nasal polyps.12,13 People
with CRSwNP experience debilitating symptoms such as nasal
obstruction, loss of smell, facial pain, sleep disturbance,
infections and nasal discharge that can significantly affect their
emotional and physical well-being.12,13 Similar
to asthma, the majority of cases of CRSwNP (85%) are driven by
chronic type 2 inflammation, which is strongly associated with
comorbidities, more severe disease, recurring symptoms and tissue
remodelling.14
About Exdensur (depemokimab)
Exdensur is the first ultra-long-acting biologic being evaluated
for certain respiratory diseases with underlying type 2
inflammation, such as severe asthma. It
combines high interleukin-5 (IL-5) binding affinity and high
potency with an extended half-life to enable twice-yearly
dosing.1 IL-5
is a key cytokine in type 2 inflammation.
More information can be found in the Exdensur Summary of Product Characteristics and
Patient Information leaflets which will be published on the MHRA
Products website within
7 days of approval.
About the SWIFT phase III trials
Results from the SWIFT trials were presented at the 2024 European
Respiratory Society International Conference and published in
the New England Journal of
Medicine.
The SWIFT-1 and SWIFT-2 clinical trials assessed the efficacy and
safety of depemokimab adjunctive therapy in 382 and 380
participants with severe asthma who were randomised to receive
depemokimab or a placebo respectively, in addition to their
standard of care (SOC) treatment with medium to high-dose inhaled
corticosteroids plus at least one additional controller. The full
analysis set in SWIFT-1 included 250 patients in the depemokimab
plus SOC arm and 132 in the placebo plus SOC arm; in SWIFT-2, 252
patients were included in the depemokimab plus SOC arm and 128 in
the placebo plus SOC arm.1
About the ANCHOR phase III trials
Results from the ANCHOR trials were presented at the 2025 American
Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy
Organization (WAO) Joint Congress and published
in The
Lancet.
ANCHOR-1 included 143 patients in the depemokimab plus SOC arm and
128 in the placebo plus SOC arm; in ANCHOR-2, 129 patients were
included in the depemokimab plus SOC arm and 128 in the placebo
plus SOC arm. All 528 patients had inadequately controlled CRSwNP,
including nasal polyps in both nasal cavities (an endoscopic
bilateral NPS ≥5), and had either undergone previous surgery
for CRSwNP, had received previous treatment with SCS or were
intolerant to SCS. Patients received depemokimab or placebo at
six-monthly intervals (26 weeks) in addition to SOC (maintenance
intranasal corticosteroids).2
About the depemokimab development programme
Depemokimab is currently being evaluated in phase III trials for
the treatment of other diseases with underlying type 2
inflammation, including OCEAN for eosinophilic granulomatosis with
polyangiitis (EGPA) and DESTINY for hyper eosinophilic syndrome
(HES). GSK has also initiated the ENDURA-1, ENDURA-2 and VIGILANT
phase III trials assessing the efficacy and safety of depemokimab
as an add-on therapy in patients with uncontrolled moderate to
severe COPD with type 2 inflammation.
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 Q3 Results for 2025.
Registered in England & Wales:
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3888792
Registered Office:
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New Oxford Street
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WC1A
1DG
References
1.
Jackson D., et al. Twice-Yearly Depemokimab in Severe Asthma with
an Eosinophilic Phenotype. NEJM.
September 2024. Vol. 391 No. 24.DOI: 10.1056/NEJMoa2406673.
2.
Gevaert, Philippe et al. Efficacy and safety of twice per year
depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1
and ANCHOR-2): phase 3, randomised, double-blind, parallel trials.
The Lancet, Volume 405, Issue 10482, 911 - 926.
DOI: 10.1016/S0140-6736(25)00197-7.
3.
World Health Organisation. Asthma Key Facts. Available at:
https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed
December 2025.
4.
Office for Health Improvement & Disparities. Respiratory
disease profile: statistical commentary, June 2025. Available at:
https://www.gov.uk/government/statistics/update-of-indicators-in-the-respiratory-disease-profile-june-2025/respiratory-disease-profile-statistical-commentary-june-2025.
Accessed December 2025.
5. "What
Is Type 2 Inflammation?" Allergy & Asthma Network, 22 May
2025, https://allergyasthmanetwork.org/health-a-z/type-2-inflammation-resources/. Accessed
December 2025.
6.
Menzies-Gow, Andrew et al. "A Renewed Charter: Key Principles to
Improve Patient Care in Severe Asthma." Advances in therapy vol.
39,12 (2022): 5307-5326. doi:10.1007/s12325-022-02340
7.
Orlovic M, Tzelis D, Guerra I, Bar-Katz V, Woolley N, Bray H,
Hanslot M, Usmani O, Madoni A. Environmental, healthcare and
societal impacts of asthma: a UK model-based assessment. ERJ Open
Res. 2024 Jul 22;10(4):00577-2023. doi:
10.1183/23120541.00577-2023. PMID: 39040585; PMCID:
PMC11261382.
8.
Global Initiative for Asthma. Global Strategy for Asthma Management
and Prevention,2024. Updated May 2024. Available at:
https://ginasthma.org/. Accessed December 2025.
9. World
Health Organisation. Asthma Key Facts. Available
at: https://www.who.int/news-room/fact-sheets/detail/asthma.
Accessed December 2025
10.
Wang E, et al. Characterization of Severe Asthma Worldwide: Data
From the International Severe Asthma Registry. CHEST, Volume 157,
Issue 4, 790 - 804.
https://doi.org/10.1016/j.chest.2019.10.053.
11.
Heaney L, et al. Eosinophilic and Noneosinophilic Asthma: An Expert
Consensus Framework to Characterize Phenotypes in a Global
Real-Life Severe Asthma Cohort. Chest.
2021;160(3):814-830.
12.
Bachert C, et al. Burden of Disease in Chronic Rhinosinusitis with
Nasal Polyps. J Asthma Allergy. 2021;b 11;14:127-134. doi:
10.2147/JAA.S290424. PMID: 33603409; PMCID:
PMC7886239.
13.
Bachert C, et al. EUFOREA expert board meeting on uncontrolled
severe chronic rhinosinusitis with nasal polyps (CRSwNP) and
biologics: Definitions and management. J Allergy Clin Immunol.
2021;147(1):29-36.
14.
Bernstein JA. Use of patient-reported outcome measures and
inflammatory biomarkers to differentiate chronic rhinosinusitis
with nasal polyp endotypes: Is it feasible? Ann Allergy Asthma
Immunol. 2023 Apr;130(4):409-410. doi: 10.1016/j.anai.2023.01.004.
PMID: 37005049.
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
16, 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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