REG - GSK PLC - Depemokimab receives positive CHMP opinion

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RNS Number : 4341L  GSK PLC  12 December 2025

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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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.     International Respiratory Coalition. Asthma. Available at:
https://international-respiratory-coalition.org/diseases/asthma/
(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
(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 (https://pubmed.ncbi.nlm.nih.gov/33065369/)

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
(https://link.springer.com/article/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 (https://onlinelibrary.wiley.com/doi/10.1111/all.13875)

8.     "What Is Type 2 Inflammation?" Allergy & Asthma Network, 22 May
2025,
https://allergyasthmanetwork.org/health-a-z/type-2-inflammation-resources/
(https://allergyasthmanetwork.org/health-a-z/type-2-inflammation-resources/) .

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