REG - GSK PLC - Positive EU opinion for GSK liquid Menveo vaccine

GSKAnnouncement

24/09/2024 07:00

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RNS Number : 2993F  GSK PLC  24 September 2024

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  (#_edn1)

 

 

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
(https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003692-61/results)
; 2017-003456-23
(https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003456-23/results)
). 2  (#_edn2) (, 3  (#_edn3) ) 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  (#_edn4) 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  (#_edn5)
 

 

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  (#_edn6)
(, 7  (#_edn7) ) 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  (#_edn8) (, 9  (#_edn9) ) 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 
(#_edn10) EMA Prescribing Information for Menveo can be accessed at:
https://www.ema.europa.eu/en/medicines/human/EPAR/menveo
(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.

 

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 1  (#_ednref1) Data on file: Menveo doses distributed in Europe from 2017 to
August 31st 2024 REF-246217

 2  (#_ednref2) 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
(https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003692-61/results)
. Accessed September 2024.

 3  (#_ednref3) 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
(https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003456-23/results)
. Accessed September 2024.

 4  (#_ednref4) World Health Organization (WHO), Meningitis Factsheet, 2023.
Available at: https://www.who.int/news-room/fact-sheets/detail/meningitis
(https://www.who.int/news-room/fact-sheets/detail/meningitis) . Accessed
September 2024.

 5  (#_ednref5) 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  (#_ednref6) Data on File; List of countries where Menveo is registered
and/or commercialized REF-194949

 7  (#_ednref7) Data on File: Menveo doses distributed from 2010 to end of
2022 REF-195452

 8  (#_ednref8) 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  (#_ednref9) 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  (#_ednref10) EMA, Menveo : EPAR - Product Information - Summary of
Product Characteristics. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/menveo
(https://www.ema.europa.eu/en/medicines/human/EPAR/menveo) . Accessed
September 2024.

 

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