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
Depemokimab receives positive CHMP opinion for severe
asthma with type 2 inflammation and chronic rhinosinusitis with
nasal polyps
●
If
approved, depemokimab will be the first and only ultra-long-acting
biologic in the EU to treat respiratory
diseases
●
Positive
opinion based on four phase III trials with statistically
significant and clinically meaningful primary endpoints across
severe asthma and chronic rhinosinusitis with nasal polyps
(CRSwNP)
●
In
Europe, an estimated 3 million people live with severe asthma and
patients with CRSwNP face poorly controlled
symptoms
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 depemokimab in two
indications:
●
as
add-on maintenance treatment for severe asthma with type 2
inflammation characterised by blood eosinophil count in adults and
adolescents 12 years and older who are inadequately controlled
despite 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 CRSwNP for whom therapy with systemic
corticosteroids and/or surgery do not provide adequate disease
control.
The European Commission decision on approval is expected in Q1
2026.
The positive opinion 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. The trials support the potential for
depemokimab to provide ultra-long-acting protection from
asthma exacerbations as
well as to alleviate symptoms associated
with CRSwNP in
just two doses a year.1,2
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology
& Inflammation R&D, GSK said: "Many
patients with severe asthma continue to face frequent
exacerbations, hospital visits and exposure to chronic oral
corticosteroids, highlighting the need for new therapies that
deliver durable control with less treatment
burden. Today's
positive CHMP opinion means that depemokimab could become the first
and only ultra-long-acting biologic approved in Europe for the
treatment of severe asthma with type 2 inflammation and CRSwNP. In
just two doses a year, depemokimab could help redefine care for
millions of patients."
Asthma affects more than 42 million people in
Europe.3 About 5-10%
of patients experience severe asthma, and many continue
to experience
exacerbations and reduced
quality of life despite
treatment.4 Depemokimab's
sustained suppression of type 2 inflammation has the potential
to address
the underlying drivers of additional diseases such
as CRSwNP, helping
to alleviate associated symptoms. 5-7
The pooled results from SWIFT 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
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 depemokimab
Depemokimab is the first ultra-long-acting biologic being evaluated
for certain respiratory diseases with underlying type 2
inflammation, such as severe asthma and CRSwNP. It
combines high interleukin-5
(IL-5) binding
affinity and high potency with an extended half-life to enable
twice-yearly dosing.1,2 IL-5
is a key cytokine in type 2 inflammation.8
Depemokimab is currently not approved anywhere in the
world.
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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Jeff McLaughlin
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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.
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.
International Respiratory Coalition. Asthma. Available
at: https://international-respiratory-coalition.org/diseases/asthma/.
Accessed December 2025.
4. 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.
5. Laidlaw
TM, et al. Chronic rhinosinusitis with nasal polyps and asthma. J
Allergy Clin Immunol. 2021;147(2):603-609. DOI: 10.1016/j.jaip.2020.09.063
6. Joustra,
Gonneke E et al. "Long-term
clinical control in chronic rhinosinusitis: Outcomes more than five
years after surgery." European archives of
oto-rhino-laryngology: official journal of the European Federation
of Oto-Rhino-Laryngological Societies (EUFOS): affiliated with the
German Society for Oto-Rhino-Laryngology - Head and Neck
Surgery vol. 282,9 (2025): 4661-4668. DOI:10.1007/s00405-025-09529-z
7.
Fokkens WJ, et al. EUFOREA consensus on biologics for CRSwNP with
or without asthma. Allergy, Volume
74, Issue 12, 2312 - 2319. DOI: 101.1111/all.13875
8. "What
Is Type 2 Inflammation?" Allergy & Asthma Network, 22 May
2025, https://allergyasthmanetwork.org/health-a-z/type-2-inflammation-resources/.
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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