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 January 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 January 2026, London, UK
Exdensur (depemokimab)
approved in Japan for severe asthma and chronic rhinosinusitis
with nasal polyps
● Exdensur is
the first and only ultra-long-acting biologic in Japan for the
treatment of severe asthma and chronic rhinosinusitis with nasal
polyps (CRSwNP)
● Approval based on data from the SWIFT and ANCHOR
phase III trials showing sustained efficacy in two doses a year
versus placebo
● Patients with severe asthma face frequent
exacerbations, hospitalisations and disease progression, requiring
an urgent need for novel solutions
GSK plc (LSE/NYSE: GSK) today announced the approval
of Exdensur (depemokimab)
by Japan's Ministry of Health, Labour and Welfare (MHLW) as a
treatment for bronchial asthma (limited to severe or refractory
patients whose asthma
symptoms cannot be controlled with existing treatments) and CRSwNP
(limited to patients inadequately controlled with standard
treatment).
The MHLW approval was based on data from
the SWIFT and ANCHOR phase III trials, which demonstrated the
sustained efficacy of a twice-yearly dose of depemokimab versus
placebo, both plus standard of care. In SWIFT-1 and SWIFT-2,
treatment with depemokimab resulted
in significant reductions in asthma exacerbations. Additionally,
ANCHOR-1 and ANCHOR-2 showed significant improvements in nasal
polyp size and nasal obstruction, two key measures of disease
severity.1,2
Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology &
Inflammation R&D, GSK said: "Building
on other recent regulatory milestones, the approval
of Exdensur in
Japan could set a new standard of care for patients with severe
asthma or CRSwNP. By delivering sustained suppression of type 2
inflammation in just two doses a year, physicians can now provide
an ultra-long-acting option to help protect against asthma
exacerbations and the debilitating symptoms of
CRSwNP."
Patients in Japan living with severe asthma can experience frequent
exacerbations and progression of their disease, leading to
hospitalisations and increased overall healthcare
costs.3-6 In
addition, patients with CRSwNP face debilitating daily symptoms and
almost half remain uncontrolled.3,7 Depemokimab
is a novel therapy that has been developed with an extended
half-life, enabling the sustained suppression of disease-driving
type 2 inflammation with twice-yearly dosing.1 These
distinct properties could potentially improve patient outcomes
while reducing health system burden.
Results from the SWIFT trials showed treatment with depemokimab
resulted in a significant 58% and 48% reduction in the rate of
annualised asthma exacerbations (asthma attacks) over 52 weeks from
SWIFT-1 and SWIFT-2, respectively [rate ratio (95% confidence
interval) p-value: SWIFT-1 0.42 (0.30, 0.59) p<0.001 and SWIFT-2
0.52 (0.36, 0.73) p<0.001] (AER depemokimab versus placebo:
SWIFT-1 0.46 vs. 1.11 and SWIFT-2 0.56 vs. 1.08 exacerbations per
year).1
In addition, results from the ANCHOR trials showed an improvement
(reduction) from baseline in nasal polyp score (scale: 0-8) at 52
weeks [treatment difference (95% confidence interval) p-value:
ANCHOR-1 -0.7 (-1.1, -0.3) p<0.001 and ANCHOR-2 -0.6 (-1.0,
-0.2) p=0.004] and in nasal obstruction verbal response scale
(scale: 0-3) over weeks 49-52 [treatment difference (95% confidence
interval) p-value: ANCHOR-1 -0.23 (-0.46, <0.00) p=0.047 and
ANCHOR-2 -0.25 (-0.46, -0.03) p=0.025].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
Approval in Japan marks the third regulatory approval for
depemokimab, following marketing authorisation from the US Food and
Drug Administration (FDA) and UK's Medicines and Healthcare
products Regulatory Agency (MHRA).8,9 Depemokimab
recently received a positive CHMP opinion in the EU and it is
currently under regulatory review in other countries, including in
China.10
About asthma
Asthma affects more than 260 million people globally, many of whom
continue to experience symptoms and exacerbations despite
treatment.11,12 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.13 Type
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).13
About CRSwNP
CRSwNP is caused by inflammation of the nasal lining that can lead
to soft tissue growths, known as nasal polyps.14,15 People
with CRSwNP experience 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.14,15 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.14-19
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. 1,2 IL-5
is a key cytokine in type 2 inflammation.
Please refer to the updated Product Information (PI) for
precautions concerning indications, dosage and administration, and
safety information in Japan which will shortly be updated at this
link: Japan Pharmaceuticals
and Medical Devices Agency.
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.1,20
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.2,21
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).22,23 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.24-26
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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WC1A
1DG
References
1. Jackson,
D, et al. "Twice-yearly
Depemokimab in severe asthma with an eosinophilic
phenotype." New England
Journal of Medicine, vol. 391, no. 24, 19 Dec. 2024,
pp. 2337-2349, https://doi.org/10.1056/nejmoa2406673.
2. Gevaert,
P, 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, vol.
405, no. 10482, Mar. 2025, pp. 911-926, https://doi.org/10.1016/s0140-6736(25)00197-7.
3. Maspero,
J, et
al. "Type
2 inflammation in asthma and other airway
diseases." ERJ Open
Research, vol. 8,
no. 3, July 2022, pp. 00576-02021, https://doi.org/10.1183/23120541.00576-2021.
4. Ding,
B, et al. "Burden of uncontrolled severe asthma with and without
elevated type-2 inflammatory biomarkers." The Journal
of Allergy and Clinical Immunology: In Practice, vol. 12, no. 4, Apr. 2024, pp.
970-982, https://doi.org/10.1016/j.jaip.2023.12.021.
5. To,
Y, et al. "Real-world treatment and health care resource use among
severe asthma patients in Japan." Respiratory
Investigation,
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no. 4, July 2021, pp. 464-477, https://doi.org/10.1016/j.resinv.2021.02.010.
6. Menzies-Gow, A., et
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renewed charter: Key principles to improve patient care in severe
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39, no. 12, 17 Oct. 2022, pp. 5307-5326, https://doi.org/10.1007/s12325-022-02340-w.
7. Seys, S,
et al. "Real‐life
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8. "Exdensur
(Depemokimab) Approved by US FDA for the Treatment of Severe
Asthma." GSK, 16 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/.
9. "Exdensur
(Depemokimab) Approved in the UK for Treatment of Asthma with Type
2 Inflammation and Chronic Rhinosinusitis with Nasal
Polyps." GSK,
15 Dec. 2025, www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-the-uk-for-treatment-of-asthma-with-type-2-inflammation-and-chronic-rhinosinusitis-with-nasal-polyps/.
10. "Depemokimab
Receives Positive CHMP Opinion for Severe Asthma with Type 2
Inflammation and Chronic Rhinosinusitis with Nasal Polyps." GSK, 12
Dec. 2025, www.gsk.com/en-gb/media/press-releases/depemokimab-receives-positive-chmp-opinion-for-severe-asthma-with-type-2-inflammation/.
11. World
Health Organisation. Asthma Key Facts. Available
at: https://www.who.int/news-room/fact-sheets/detail/asthma.
Accessed February 2025.
12. 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.
13. Heaney,
L, et al. "Eosinophilic and noneosinophilic
asthma." CHEST,
vol. 160, no. 3, Sept. 2021, pp. 814-830, https://doi.org/10.1016/j.chest.2021.04.013.
14. Bachert,
C, et al. "Burden of disease in chronic rhinosinusitis with nasal
polyps." Journal of Asthma and Allergy, Volume 14, Feb. 2021, pp.
127-134, https://doi.org/10.2147/jaa.s290424.
15. Bachert,
C, et al. "EUFOREA expert board meeting on uncontrolled severe
chronic rhinosinusitis with nasal polyps (CRSwNP) and Biologics:
Definitions and management." Journal of
Allergy and Clinical Immunology, vol. 147, no. 1, Jan. 2021, pp.
29-36, https://doi.org/10.1016/j.jaci.2020.11.013.
16. Bernstein,
J. "Use of patient-reported outcome measures and inflammatory
biomarkers to differentiate chronic rhinosinusitis with nasal polyp
endotypes: Is it feasible?" Annals of
Allergy, Asthma & Immunology, vol. 130, no. 4, Apr. 2023, pp.
409-410, https://doi.org/10.1016/j.anai.2023.01.004.
17. Laidlaw,
T, et al. "Chronic rhinosinusitis with nasal polyps and
asthma." The Journal
of Allergy and Clinical Immunology: In Practice, vol. 9, no. 3, Mar. 2021, pp.
1133-1141, https://doi.org/10.1016/j.jaip.2020.09.063.
18. De
Corso, E, et al. "How
to manage recurrences after surgery in CRSWNP patients in the
biologic era: A narrative review." Acta
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Apr. 2023, https://doi.org/10.14639/0392-100x-suppl.1-43-2023-01
19. Chen,
S, et al. "Systematic literature review of the epidemiology and
clinical burden of chronic rhinosinusitis with nasal
polyposis." Current
Medical Research and Opinion, vol. 36, no. 11, 25 Sept. 2020,
pp. 1897-1911, https://doi.org/10.1080/03007995.2020.1815682.
20. Jackson,
D, et al. "Late
breaking abstract - depemokimab efficacy/safety in patients with
asthma on medium/high-dose ICS: The phase IIIA randomised SWIFT-1/2
studies." European
Respiratory Journal 2024, vol. 64, no. 68, 14 Sept.
2024, https://doi.org/10.1183/13993003.congress-2024.rct3718.
21. Han, J,
et al. Efficacy and Safety of Twice-Yearly Depemokimab in Patients
With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): The Phase
III Randomized, Double-Blind, Placebo-Controlled Replicate
ANCHOR-1/2 Trials. Journal of
Allergy and Clinical Immunology, Volume 155, Issue 2,
AB443. www.jacionline.org
22. "Efficacy
and Safety of Depemokimab Compared With Mepolizumab in Adults With
Relapsing or Refractory Eosinophilic Granulomatosis With
Polyangiitis (EGPA) (OCEAN)." Clinicaltrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05263934.
Accessed 8 Dec. 2025.
23. "Depemokimab
in Participants With Hypereosinophilic Syndrome, Efficacy, and
Safety Trial (DESTINY)." Clinicaltrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT05334368.
Accessed 8 Dec. 2025.
24. "Depemokimab
as an Extended treatmeNt Duration Biologic in Adults With Chronic
Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
(ENDURA -1) (ENDURA -1)." ClinicalTrials.Gov,
GlaxoSmithKline, www.clinicaltrials.gov/study/NCT06959095.
Accessed 8 Dec. 2025.
25. "Depemokimab
as an Extended treatmeNt Duration Biologic in Adults With Chronic
Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
(ENDURA-2) (ENDURA-2)." Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06961214.
Accessed 17 Dec. 2025.
26. "eValuating
the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN
Chronic Obstructive Pulmonary Disorder (COPD) With Type 2
Inflammation (VIGILANT)." Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT07177339.
Accessed 17 Dec. 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: January
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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