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 September 2024
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: 24 September 2024, London UK
GSK's Menveo meningococcal vaccine in new single-vial,
fully liquid presentation receives positive European CHMP
opinion
● If
approved, the fully liquid presentation will offer healthcare
providers an option that does not require reconstitution
of Menveo (MenACWY
vaccine) before use
● Marketing
authorisation in EU expected by November
2024
●
Over 6 million doses of GSK's MenACWY vaccine have been
distributed to European countries since 2017 to help protect
against invasive meningococcal disease[1]
GSK plc (LSE/NYSE: GSK) today announced that the European Medicine
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) has recommended for use a single-vial, fully liquid
presentation of Menveo (Meningococcal Group A, C, W-135 and Y
conjugate vaccine, MenACWY vaccine) to help protect against
invasive meningococcal disease (IMD) caused by bacterial groups A,
C, W, and Y.
If approved, this single-vial presentation will be licenced for
active immunisation of children from 2 years of age, adolescents
and adults, offering healthcare providers an option that does not
require reconstitution before its use.
Philip Dormitzer, GSK Head of Global Vaccines Research &
Development, said: "As a
global leader in meningococcal vaccines, we are committed to
finding innovative solutions that simplify immunisation against
bacterial meningitis, support vaccine uptake and help protect as
many people as possible from this devastating disease. We will
continue our efforts to help prevent this disease in at-risk
populations in the European Union."
GSK's submission to the EMA is based on two positive
Phase IIb trials (2017-003692-61; 2017-003456-23).[2],[3] The
primary and secondary outcomes of these trials, supported by
post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable
immunogenicity, tolerability and a comparable safety profile to the
existing lyophilized/liquid formulation. Today's positive opinion
marks one of the final steps prior to the potential extension of
the marketing authorisation by the European Commission (EC). The
EC's final decision is expected by November
2024.
IMD is an unpredictable but serious illness that can cause
life-threatening complications.[4] Despite
treatment, among those who contract IMD one in six will die,
sometimes in as little as 24 hours.4 One
in five survivors may suffer long-term consequences such as brain
damage, amputations, hearing loss and nervous system
problems.4 Although
anyone can get IMD, babies, young children and those who are in
their late teens and early adulthood are amongst the groups at
higher risk.4
The original presentation of Menveo that requires reconstitution
and which was approved by the EMA in 2010 is unaffected by this
recommendation.[5]
About Menveo
GSK's MenACWY vaccine has received regulatory approval in over 60
countries, with more than 82 million doses distributed worldwide
since 2010.[6],[7] Over
6 million doses have been distributed to European countries since
2017.1 It
offers evidence of immunogenicity with a well-characterised safety
profile.[8],[9] In
the European Union (EU), this vaccine has received regulatory
approval for active immunisation to prevent IMD caused
by Neisseria
meningitidis serogroups A, C, Y, and W
in children
from 2 years of age, adolescents and adults.[10] EMA
Prescribing Information for Menveo can
be accessed at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo
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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(Washington DC)
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Investor Relations:
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(London)
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(London)
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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 Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
[1] Data
on file: Menveo doses
distributed in Europe from 2017 to August 31st
2024 REF-246217
[2] EU
Clinical Trials Register, A phase 2b,
randomized, controlled, observer-blind, multi-center,
non-inferiority immunogenicity and safety study of two formulations
of GSK Biologicals' Meningococcal ACWY conjugate vaccine
(GSK3536820A and Menveo) administered to healthy adults 18 to 40
years of age. Available
at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003692-61/results.
Accessed September 2024.
[3] EU
Clinical Trials Register, A phase 2b,
randomized, controlled, observer-blind, multi-center study to
evaluate safety and immunogenicity of different formulations of GSK
Biologicals' Meningococcal ACWY conjugate vaccine (GSK3536820A and
Menveo) administered to healthy adolescents and young adults 10 to
40 years of age.. Available
at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003456-23/results.
Accessed September 2024.
[4] World
Health Organization (WHO), Meningitis
Factsheet,
2023. Available at: https://www.who.int/news-room/fact-sheets/detail/meningitis.
Accessed September 2024.
[5] EC
Decision C(2010)1795 of 16 March 2010 and subsequent amendments;
marketing authorisation numbers EU/1/10/614/002 &
EU/1/10/614/003
[6] Data
on File; List of
countries where Menveo is registered and/or
commercialized REF-194949
[7] Data
on File: Menveo doses
distributed from 2010 to end of 2022 REF-195452
[8] Becerra-Culqui
TA, Sy LS, Ackerson BK, et al. Safety
of quadrivalent meningococcal conjugate vaccine in infants and
toddlers 2 to 23-months old. Vaccine. 2020; 38(2),
228-234.
[9] Khatami
A, Snape MD, Davis E, et al. Persistence
of the immune response at 5 years of age following infant
immunisation with investigational quadrivalent MenACWY conjugate
vaccine formulations. Vaccine. 2012; 30:2831-2838.
10.1016/j.vaccine.2012.02.04
[10] EMA, Menveo
: EPAR - Product Information - Summary of Product
Characteristics. Available
at: https://www.ema.europa.eu/en/medicines/human/EPAR/menveo. Accessed
September 2024.
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: September
24, 2024
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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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