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 December 2025
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: 16 December 2025, London, UK
Exdensur (depemokimab)
approved by US FDA for the treatment of severe
asthma
●
Exdensur is
the first and only ultra-long-acting biologic with twice-yearly
dosing approved for patients with severe asthma with an
eosinophilic phenotype
●
Approval based on SWIFT trials showing significantly lower
rate of annualised asthma exacerbations in patients receiving
depemokimab versus placebo
● SWIFT data included
reduction in exacerbations
requiring hospitalisation and/or emergency department visits
with depemokimab
●
An
estimated 2 million Americans live with severe asthma and 50%
continue to experience frequent exacerbations and hospitalisations
requiring novel solutions
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance
treatment of severe asthma characterised by an eosinophilic
phenotype in adult and paediatric patients aged 12 years and
older.
The FDA approval of Exdensur is
based on data from the SWIFT-1 and SWIFT-2 phase III trials. In
these studies, depemokimab demonstrated
sustained exacerbation reduction with two doses per year versus
placebo, both plus standard of care. 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). Across these trials, depemokimab was well-tolerated,
with patients experiencing a similar rate and severity of side
effects as those receiving placebo.1
Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology
& Inflammation R&D, GSK said: "Physicians
in the US now have the option to provide sustained protection from
exacerbations for patients living with severe asthma with an
eosinophilic phenotype in just two doses a
year. Exdensur could
redefine patient care and further establish the use of biologics
for those who continue to experience exacerbations despite
treatment."
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.
An estimated 2 million Americans live with severe asthma and half
continue to experience frequent exacerbations that may lead to
hospitalisations, emergency department visits and corresponding
increased health system costs.2,3,4 While
biologics have demonstrated benefit in controlling severe asthma,
only 20% of eligible patients in the US currently receive one,
increasing their risk of exacerbations and worsening
disease.5 Longer
dosing intervals have been associated with an increased likelihood
that patients would consider a biologic and 73% of physicians
believe it would be beneficial.6,7
Geoffrey Chupp, MD, Professor of Medicine, Pulmonary, Critical Care
and Sleep Medicine, Yale University said: "Current biologic treatments for asthma are
often underutilised and frequent injections can be inconvenient for
many patients and lead to inconsistent use. There is clearly an opportunity to provide a
longer duration of protection from exacerbations between injections
for severe asthma patients that reduces the frequency of doses and
may improve overall health care
utilisation. Exdensur could empower physicians and patients to
potentially achieve their treatment goals with fewer
injections."
Tonya Winders, President and CEO, Global Allergy & Airways
Patient Platform said: "The
struggle for people living with severe asthma is immense, with many
silently enduring continued symptom recurrence and exacerbations.
An innovative treatment option like Exdensur that offers the long-acting protection from
exacerbations that severe asthma patients with an eosinophilic
phenotype deserve, with the benefit of fewer doses, is truly
welcome."
Depemokimab recently received marketing authorisation from the UK's
Medicines and Healthcare products Regulatory Agency (MHRA) and a
positive CHMP opinion in Europe, with an approval decision expected
in Q1 2026. Regulatory submissions are also under review across the
globe, including in China and Japan.
About severe asthma
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.8 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).9
About Exdensur (depemokimab-ulaa)
Exdensur is
the first ultra-long-acting biologic being evaluated for certain
respiratory diseases with underlying type 2 inflammation, such as
severe asthma. It has been developed with an extended half-life to
enable twice-yearly dosing.1
Please see accompanying US Prescribing
Information here.
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
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 depemokimab development
programme
The phase III programme consists of SWIFT-1 and SWIFT-2 in severe
asthma, with an open label extension study (AGILE), and the
ANCHOR-1 and ANCHOR-2 trials in chronic rhinosinusitis with nasal
polyps (CRSwNP).1,10,11 Depemokimab
is currently being evaluated in phase III trials for the treatment
of other diseases with underlying type 2 inflammation, including
OCEAN for EGPA and DESTINY for 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
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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GSK enquiries
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Media:
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Tim Foley
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Sarah Clements
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(London)
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Kathleen Quinn
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Constantin Fest
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+44 (0) 7831 826525
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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Sam Piper
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Steph Mountifield
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+44 (0) 7796 707505
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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Frannie DeFranco
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+1 215 751 3126
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(Philadelphia)
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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:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1. Jackson, David J., 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. Wang, Eileen, et al.
"Characterization of severe asthma
worldwide." CHEST, vol. 157, no. 4, Apr. 2020, pp. 790-804,
https://doi.org/10.1016/j.chest.2019.10.053.
3. Menzies-Gow, Andrew, 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.
4. "Cost
of Asthma on Society." Cost of Asthma on
Society, Asthma & Allergy
Foundation of America, 31 Jan. 2025, https://www.aafa.org/advocacy/key-issues/access-to-health-care/cost-of-asthma-on-society.
5. Park, Jihye, et al.
"Unmet treatment needs in asthma patients with eosinophilic
phenotype: A US claims-based study on asthma exacerbations and
Healthcare Resource Utilization." CHEST, vol. 166, no. 4, Oct. 2024,
https://doi.org/10.1016/j.chest.2024.06.2816.
6. Tal-Singer,
Ruth, et al. "Disease impact and perception of
biologics in adults with type 2 inflammation respiratory disease:
International survey results." Patient
Preference and Adherence, Volume 19, Apr. 2025, pp.
1159-1170, https://doi.org/10.2147/ppa.s517466.
7.
Research Partnership Quant uptake Market Research, 200 HCPs Top two
box on a seven-point scale where seven equaled "highly
beneficial".
8. Brussino, Luisa, et al.
"Is it severe asthma or asthma with severe
comorbidities?" Journal of Asthma and
Allergy, Volume 10, Nov. 2017,
pp. 303-305,
https://doi.org/10.2147/jaa.s150462.
9. Heaney,
Liam G., 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.
10.
"An Open-Label Extension Study of GSK3511294 (Depemokimab) in
Participants Who Were Previously Enrolled in 206713 (NCT04719832)
or 213744 (NCT04718103) (AGILE)." ClinicalTrials.gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT05243680. Accessed 8
Dec. 2025.
11. Gevaert P, Desrosiers M,
Cornet M, Mullol J, De Corso E, Keles Turel N, Maspero J, Fujieda
S, Zhang L, Sousa AR, Woods SJ, Davis AM, Schalkwijk S, Edwards D,
Ranganathan P, Follows R, Marshall C, Han JK; ANCHOR-1 and ANCHOR-2
trial investigators. 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. Lancet. 2025 Mar 15;405(10482):911-926. doi:
10.1016/S0140-6736(25)00197-7.
12.
"Efficacy and Safety of Depemokimab Compared With Mepolizumab in
Adults With Relapsing or Refractory Eosinophilic Granulomatosis
With Polyangiitis (EGPA) (OCEAN)." ClinicalTrials.gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT05263934. Accessed 8
Dec. 2025.
13.
"Depemokimab in Participants With Hypereosinophilic Syndrome,
Efficacy, and Safety Trial (DESTINY)." ClinicalTrials.gov,
GlaxoSmithKline, 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) (ENDURA -1)." ClinicalTrials.Gov,
GlaxoSmithKline, clinicaltrials.gov/study/NCT06959095. Accessed 8
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: December
17, 2025
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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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