REG - GSK PLC - Exdensur (depemokimab) UK MHRA approval

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RNS Number : 6661L  GSK PLC  16 December 2025

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 globally(3) 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
(https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/)
, 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.(10)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).(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 (https://products.mhra.gov.uk/)  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.

 

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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. (https://www.nejm.org/doi/pdf/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.
(https://doi.org/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/
(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
(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.

 

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