REG - GSK PLC - Exdensur approved by the European Commission

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RNS Number : 2268T  GSK PLC  17 February 2026

Issued: 17 February 2026, London UK

 

Exdensur (depemokimab) approved by the European Commission for severe asthma
with type 2 inflammation and chronic rhinosinusitis with nasal polyps

 

·   Exdensur is the first and only ultra-long-acting biologic in the EU to
treat respiratory diseases

·   Approval based on four phase III trials with statistically significant
and clinically meaningful primary data across severe asthma and chronic
rhinosinusitis with nasal polyps (CRSwNP)

·   An estimated 3 million people live with severe asthma in Europe and
patients with CRSwNP face inadequately controlled symptoms

 

 

GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved
Exdensur (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 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: "The approval of Exdensur in the EU means
there is now an innovative ultra-long-acting option that offers sustained
efficacy over 6 months to protect patients from severe asthma exacerbations
and the debilitating symptoms associated with CRSwNP. Exdensur may help
redefine care for the millions of patients living with these persistent and
burdensome conditions, supporting them in achieving their treatment goals with
just two doses a year."

 

Asthma affects more than 42 million people in Europe.(3) About 5-10% of
patients experience severe asthma with many continuing to experience
exacerbations and reduced quality of life despite treatment.(4) In addition,
patients with CRSwNP face debilitating daily symptoms and almost half remain
uncontrolled.(5,6) Exdensur is a novel therapy that combines high
interleukin-5 (IL-5) binding affinity and high potency with an extended
half-life, enabling the sustained suppression of disease-driving type 2
inflammation with twice-yearly dosing that could address the continued unmet
need in these diseases.(1)

( )

Stephanie Korn, MD, PhD, Head of the Clinical Research Centre IKF Pneumologie
Mainz, said: "People living with the burden of severe asthma face persistent
exacerbations driven by uncontrolled type 2 inflammation. A new option with
twice-yearly dosing that could provide sustained suppression of type 2
inflammation is a promising innovation for patients in Europe with severe
asthma who are in urgent need of novel solutions."

 

Eugenio De Corso, MD, PhD, Professor at University of Perugia, said: "CRSwNP
profoundly impacts a patient's daily life, causing debilitating nasal
obstruction which can make breathing, smell, sleeping and other fundamental
activities a major challenge. An innovative treatment option
like Exdensur, that could help patients achieve their treatment goals in
fewer doses, represents an important advance."

 

In the SWIFT phase III trials 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 a secondary endpoint from SWIFT-1 and SWIFT-2, patients treated with
depemokimab experienced numerically fewer exacerbations requiring
hospitalisation and/or emergency department visits (1% and 4%) compared with
placebo (8% and 10%), respectively. A pre-specified pooled analysis of the two
trials showed there was a 72% reduction in the annualised rate of clinically
significant exacerbations requiring hospitalisation and/or ED visits over 52
weeks for depemokimab compared with placebo [rate ratio 0.28, 95% CI (0.13,
0.61), nominal p=0.002] (AER depemokimab 0.02 versus placebo 0.09).(1) The
full 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/pdf/10.1056/NEJMoa2406673) .(1,7)

 

Additionally, in the ANCHOR phase III trials, treatment with depemokimab
resulted in 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)
The full 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)
.(2,8)

( )

Across these trials, depemokimab was well-tolerated, with patients
experiencing a similar rate and severity of side effects as those receiving
placebo.(1,2)

 

Exdensur recently received approval in the US for the treatment of severe
asthma, as well as marketing authorisation in the UK and Japan for the
treatment of severe asthma and CRSwNP.(9-11  )

 

About the SWIFT phase III trials

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

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 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 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.

 

For product and important safety information please consult the country's
relevant summary of product characteristics. The EU information is available
at: https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur
(https://www.ema.europa.eu/en/medicines/human/EPAR/exdensur)

 

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).(12,13) 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.(14-16)

 

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 www.gsk.com
(https://www.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 Q4 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.     International Respiratory Coalition. Asthma. Available
at: https://international-respiratory-coalition.org/diseases/asthma/
(https://international-respiratory-coalition.org/diseases/asthma/) . Accessed
January 2026.

4.     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) .

5.     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.
(https://publications.ersnet.org/content/erjor/8/3/00576-2021)

6.     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)

7.     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) .

8.     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 (http://www.jacionline.org)

9.     "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/)
.

10.    "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/)
.

11.    "Exdensur (depemokimab) approved in Japan for severe asthma and
chronic rhinosinusitis with nasal polyps." GSK, 6 Jan. 2026,
https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/
(https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/)
.

12.    "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.

13.    "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.

14.    "Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
(ENDURA-1)." ClinicalTrials.Gov, GlaxoSmithKline,
www.clinicaltrials.gov/study/NCT06959095
(http://www.clinicaltrials.gov/study/NCT06959095) . Accessed 8 Dec. 2025.

15.    "Depemokimab as an Extended treatmeNt Duration Biologic in Adults
With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation
(ENDURA-2)." Clinicaltrials.Gov, www.clinicaltrials.gov/study/NCT06961214
(http://www.clinicaltrials.gov/study/NCT06961214) . Accessed 8 Dec. 2025.

16.    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
(https://www.clinicaltrials.gov/study/NCT07177339) . Accessed 17 Dec. 2025.

 

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