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 January 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:
27 January 2025, London UK
GSK's Shingrix new
prefilled syringe presentation accepted for review by European
Medicines Agency
●
If approved, the new presentation will offer a
convenient administration option to healthcare
professionals
● Over 25 million people in Europe have received
GSK's shingles vaccine since 2018[5]
GSK plc
(LSE/NYSE: GSK) today announced that the European Medicines Agency
(EMA) has accepted for review the regulatory application of a
prefilled syringe presentation of Shingrix (GSK's Recombinant Zoster
Vaccine or RZV) for the prevention of shingles (herpes
zoster).
The new
prefilled syringe removes the need to reconstitute separate vials
prior to administration, offering a convenient option for
physicians, pharmacists and other healthcare professionals who
administer vaccinations. The current presentation of the vaccine
consists of a lyophilised (powder) antigen and a liquid adjuvant,
which healthcare professionals combine prior to administering. The
new presentation has the same composition as the reconstituted
vaccine and the submission is based on data demonstrating
comparability between the two.5
This
European regulatory review follows the file acceptance by the US
FDA on 8 January 2025 for the new prefilled syringe presentation,
continuing GSK's commitment to providing solutions to increasing
adult immunisation. GSK is also investigating submission of this
presentation to other markets. GSK's shingles vaccine has been
approved in the European Union for the prevention of herpes zoster
(HZ) and post-herpetic neuralgia (PHN) in adults aged 50 years and
older since 2018; and in adults 18 years and older at increased
risk of HZ, since 2020.[6]
About shingles
Shingles
typically presents as a rash, with painful blisters across the
chest, abdomen or face.[7] Following
the rash, up to 30% of people experience PHN,[8] a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several years.1 Shingles is
also associated with significant healthcare and human cost, with
57% of people with shingles reported missing work for an average of
9.1 days.[9]
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox.1 By age 50, VZV is present in most
adults[10] and
in some may reactivate with advancing age.7 As people age, the strength of the immune
system response to infection wanes, increasing the risk of
developing shingles.7
About Shingrix (Recombinant Zoster
Vaccine or RZV)
Shingrix (GSK's Recombinant Zoster Vaccine or RZV) is a
non-live, recombinant subunit vaccine indicated for the prevention
of shingles in adults 50 and over. It combines an antigen,
glycoprotein E, with an adjuvant system, AS01B, and may help
overcome the natural age-related decline in responses to
immunisation that contributes to the challenge of protecting adults
aged 50 and over from shingles.[11],[12] RZV
is not indicated to prevent primary varicella infection
(chickenpox). In several countries, RZV is also approved for adults
aged 18 years or over at increased risk for shingles. The use of
RZV should be in accordance with official recommendations and local
product label.
Please
refer to the Product Information (PI) for important dosage,
administration, and safety information in Europe available at this
link: https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
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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+44 (0)
20 8047 5502
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(London)
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Simon
Moore
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Alison
Hunt
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+1 540
742 3391
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(Washington
DC)
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Investor
Relations:
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Annabel
Brownrigg-Gleeson
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+44 (0)
7901 101944
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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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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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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 4855
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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 under Item 3.D
"Risk factors" in GSK's Annual Report on Form 20-F for 2023, and
GSK's Q3 Results for 2024.
Registered
in England & Wales:
No.
3888792
Registered
Office:
79
New Oxford Street
London
WC1A
1DG
References
[1]. Harpaz R, et al. Advisory
Committee on Immunization Practices (ACIP), Centers for Disease
Control and Prevention (CDC). Prevention of herpes zoster:
recommendations of the Advisory Committee on Immunization Practices
(ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30.
[2]. Australian Institute of
Health and Welfare. Shingles in Australia. Available
at: https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx Last
Accessed: November 2024.
[3]. Lee C, et al. Lifetime
risk of herpes zoster in the population of Beijing, China. Public
Health Pract (Oxf). 2023;5:100356.
[4]. Curran D, et al.
Meta-Regression of Herpes Zoster Incidence Worldwide. Infect Dis
Ther. 2022;11(1):389-403.
[5]. GSK data on file
2024.
[6]. Shingrix EU product
information. https://www.ema.europa.eu/en/documents/product-information/shingrix-epar-product-information_en.pdf Last
accessed: November 2024.
[7]. Mueller, N.H., et
al. Varicella zoster virus infection: clinical
features, molecular pathogenesis of disease, and
latency. Neurologic
clinics.
2008;26(3):675-97.
[8]. Kawai, K., et al.
Systematic review of incidence and complications of herpes zoster:
towards a global perspective. BMJ open. 2014;4(6).
[9]. Rampakakis E, Stutz M,
Kawai K, Tsai TF, Cheong HJ, Dhitavat J, et al. Association between
work time loss and quality of life in patients with Herpes Zoster:
a pooled analysis of the MASTER studies. Health and Quality of Life
Outcomes. 2017;15(1).
[10]. Johnson, R.W., et
al. Herpes zoster epidemiology, management, and
disease and economic burden in Europe: a multidisciplinary
perspective. Therapeutic advances in vaccines.
2015;3(4):109-20.
[11]. Cunningham, AL, et al.
Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of
Age or Older. New England Journal of Medicine.
2016;375(11):1019-32.
[12]. The GSK proprietary AS01
adjuvant system contains QS-21 Stimulon® adjuvant licensed
from Antigenics LLC, a wholly owned subsidiary of Agenus Inc.
(NASDAQ: AGEN), MPL and liposomes.
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: January
27, 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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