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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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:
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Registered Office:
79 New Oxford Street
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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.
[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