REG - GSK PLC - Exdensur approved in Japan

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RNS Number : 7169N  GSK PLC  06 January 2026

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 (https://www.pmda.go.jp/PmdaSearch/iyakuSearch/) .

 

About the SWIFT phase III trials

Results from the SWIFT trials were presented at the 2024 European Respiratory
Society International Conference
(https://publications.ersnet.org/content/erj/64/suppl68/rct3718) and published
in the New England Journal of Medicine
(https://www.nejm.org/doi/10.1056/NEJMoa2406673?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed)
.(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
(https://www.jacionline.org/article/S0091-6749(24)02307-8/fulltext) and
published in The Lancet
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00197-7/abstract)
.(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.

 

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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
(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
(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:// (https://doi.org/10.1183/23120541.00576-2021) doi
(https://doi.org/10.1183/23120541.00576-2021) .org/
(https://doi.org/10.1183/23120541.00576-2021) 10.1183/23120541.
(https://doi.org/10.1183/23120541.00576-2021) 00576-2021
(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
(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, vol. 59,
no. 4, July 2021, pp. 464-477, https://doi.org/10.1016/j.resinv.2021.02.010
(https://doi.org/10.1016/j.resinv.2021.02.010) .

6.     Menzies-Gow, A., et al. "A renewed charter: Key principles to
improve patient care in severe asthma." Advances in Therapy, vol. 39, no. 12,
17 Oct. 2022, pp. 5307-5326, https://doi.org/10.1007/s12325-022-02340-w
(https://doi.org/10.1007/s12325-022-02340-w) .

7.     Seys, S, et al. "Real‐life assessment of chronic rhinosinusitis
patients using mobile technology: The mysinusitiscoach project by Euforea."
Allergy, vol. 75, no. 11, 19 June 2020, pp. 2867-2878,
https://doi.org/10.1111/all.14408 (https://doi.org/10.1111/all.14408) .

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/
(http://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/
(http://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/
(http://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
(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
(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
(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
(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
(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
(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
(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
Otorhinolaryngologica Italica, vol. 43, no. 2 (Suppl. 1), Apr. 2023,
https://doi.org/10.14639/0392-100x-suppl.1-43-2023-01
(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
(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
(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
(https://www.jacionline.org/action/showPdf?pii=S0091-6749%2824%2902307-8)

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
(http://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
(http://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
(http://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
(http://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
(http://www.clinicaltrials.gov/study/NCT07177339) . Accessed 17 Dec. 2025.

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