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: 10 January 2025, London UK
GSK's Shingrix new
prefilled syringe presentation accepted for review by US
FDA
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If
approved, the new presentation will offer a convenient
administration option to healthcare professionals
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Over 90 million doses of GSK's
shingles vaccine have been distributed in the US since
2017[1]
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An
FDA decision on the application is expected by 20 June
2025
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) 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
pharmacists, physicians 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. 1
Today's announcement marks an important regulatory milestone for
GSK's shingles vaccine, which has been approved in the US for the
prevention of shingles in adults aged 50 years and older since
2017; and in adults 18 years and older, who are or will be at
increased risk of shingles due to immunodeficiency or
immunosuppression caused by known disease or therapy, since
2021.
[2] It
reflects GSK's continued innovation on its commercialised portfolio
to meet the needs of the healthcare community.
About shingles
Shingles is a painful, blistering rash that can last for weeks.
Approximately 99% of US adults over 50 years old have the virus
that causes shingles inside their body, although not everyone will
develop shingles. [3] An
estimated one million people develop shingles annually in the
US. 3
Shingles is caused by the reactivation of the varicella-zoster
virus (VZV), the same virus that causes
chickenpox. [4] By
age 50, VZV is present in most adults[5] and
may reactivate with advancing age. [6] As
people age, the strength of the immune system response to infection
wanes, increasing the risk of developing
shingles. 6
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. [7],[8] 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.
The following information is based on the US Prescribing
Information (PI) for Shingrix.
Please refer to the US PI at this link: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF
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]. GSK data
on file 2024.
[2].
Shingrix prescribing information. SHINGRIX
(Zoster Vaccine Recombinant, Adjuvanted), suspension for
intramuscular injection. Last accessed: January
2025.
[3]. CDC.
About Shingles (Herpes Zoster). Available at https://www.cdc.gov/shingles/about/index.html.
Last accessed: January 2025.
[4]. 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.
[5]. 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.
[6]. Mueller,
N.H., et al. Varicella zoster virus infection: clinical features,
molecular pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[7].
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.
[8]. 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 10, 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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