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 February 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: 15 February
2025, London UK
Penmenvy, GSK's 5-in-1
meningococcal vaccine, approved by US FDA to help protect against
MenABCWY
●
Vaccine helps protect against
five common disease-causing serogroups of Neisseria
meningitidis (A, B, C, W and
Y)
●
Broad serogroup coverage in one
vaccine reduces injections to help improve vaccination rates and
help protect more US adolescents and young
adults
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
GSK plc (LSE/NYSE: GSK) today announced that the
US Food and Drug Administration (FDA) has
approved Penmenvy (Meningococcal Groups A, B, C, W, and Y
Vaccine) for use in individuals aged 10 through 25
years. The vaccine targets five major serogroups
of Neisseria
meningitidis (A, B, C, W,
and Y) which commonly cause invasive meningococcal disease
(IMD).1,2
The vaccine combines the antigenic components of
GSK's two well-established meningococcal
vaccines, Bexsero (Meningococcal Group B Vaccine)
and Menveo (Meningococcal [Groups A, C, Y, and W-135]
Oligosaccharide Diphtheria CRM197 Conjugate
Vaccine). The regulatory application was
supported by positive results from two phase III trials
[NCT04502693; NCT04707391],
which evaluated the vaccine's safety, tolerability, and immune
response in over 4,800 participants aged 10-25 years. The
safety data demonstrated that the vaccine has a safety profile
consistent with GSK's licensed meningococcal
vaccines.3-5
Tony Wood, Chief Scientific
Officer, GSK, said: "We
are excited about the opportunities ahead to help improve
meningococcal vaccination coverage in the United States, especially
for IMD caused by serogroup B. Building on our global leadership in
meningococcal vaccination and our longstanding commitment to
address unmet need in disease prevention, we aim to help protect more teens and young
adults at a life stage when they are at an increased
risk."
Integrating GSK's MenABCWY vaccine into healthcare
provider practices could simplify meningococcal vaccination
delivery and help protect more US adolescents against these five
common disease-causing serogroups - A, B, C, W, and Y - for which
the US Centers for Disease Control and Prevention (CDC) have issued
recommendations.6 Although
MenB is the leading cause of IMD among this population, less than
13% receive the recommended two-dose vaccination series; around 32%
receive at least one dose.7,8 Three
of every four MenB doses currently administered in the US are
manufactured by GSK,9 positioning
the company well to lead in the US market as MenB-containing
vaccinations must be completed with the same manufacturer's MenB
vaccine.
Judy Klein, President and
Founder of Unity Consortium, a non-profit organization focused on
adolescent health and immunization in the US, said: "The
consequences of IMD can be devastating for those who contract it,
for their families and friends. We welcome new tools to help
protect more adolescents from meningococcal disease. Pentavalent
MenABCWY vaccines could help address the disease by providing
protection against the five vaccine-preventable serogroups in one
vaccine and making it easier for adolescents to get the coverage
they need."
At
its meeting on February 26, 2025, the CDC's Advisory Committee on
Immunization Practices (ACIP) is expected to vote on
recommendations for the appropriate use of GSK's MenABCWY vaccine
in adolescents and young adults.
About IMD
IMD is an uncommon but serious illness that can
lead to death for up to one in six of those who contract it in as
little as 24 hours from onset, despite
treatment.10,11 IMD
is easily misdiagnosed, with early symptoms often mistaken for the
flu.11,12 Approximately
one in five survivors may experience long-term consequences such as
brain damage, amputations, hearing loss, and nervous system
problems.10,12 Although
anyone can get IMD, adolescents and young adults between the ages
of 16 and 23 years are one of the groups at highest risk due to
common behaviours that help transmit the bacteria that cause IMD
such as living in close quarters like college dormitories, kissing
and sharing drinks, utensils, or smoking
devices.13,14
About Penmenvy
GSK's MenABCWY vaccine is an injectable suspension
for intramuscular use. The vaccine is supplied as one vial of
lyophilized MenACWY Component (powder) which is reconstituted at
the time of use with the accompanying prefilled syringe of MenB
Component (liquid). It is indicated in the US for active
immunization to prevent invasive disease caused
by Neisseria
meningitidis serogroups A,
B, C, W, and Y. It is approved in the US for use in individuals
aged 10 through 25 years. The US Prescribing Information is
available here.15
About Bexsero
GSK's MenB vaccine has received regulatory
approval in over 55 countries, including the US, and is used in 18
national immunisation programmes worldwide for the prevention of
IMD caused by Neisseria
meningitidis serogroup B.
More than 110 million doses have been distributed worldwide since
2015.16 It
is supported by clinical data supporting its effectiveness in
helping to protect adolescents and young adults against diverse
disease-causing strains of MenB, with a well-characterised safety
profile. In the US, this vaccine has received regulatory approval
for active immunisation to prevent invasive disease caused
by Neisseria
meningitidis serogroup B
and is approved for use in individuals aged 10 through 25 years.
The US Prescribing Information is
available here.17
About Menveo
GSK's MenACWY vaccine has
received regulatory approval in over 60 countries, including the
US, with more than 80 million doses distributed worldwide since
2010.18 It
offers evidence of immunogenicity with a well-characterised safety
profile. In the US, this vaccine has received regulatory approval
for active immunisation to prevent IMD caused
by Neisseria
meningitidis serogroups A, C, Y, and W
in individuals from 2 months through 55 years of age. The US
Prescribing Information is available here.19
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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Simon Moore / Dan Smith / Sarah Clements
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+44 (0) 20 8047 5502
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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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 Q4 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References:
1. Centers
for Disease Control and Prevention. About
Meningococcal Disease. Available
at: https://www.cdc.gov/meningococcal/about/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fmeningococcal%2Fabout%2Fcauses-transmission.html. Accessed
February 2025.
2. European
Centers for Disease Control and
Prevention. Factsheet
about meningococcal disease. Available
at: https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet.
Accessed February 2025.
3. GSK. GSK's
5-in-1 meningococcal ABCWY vaccine candidate accepted for
regulatory review by US FDA. Available
at: https://www.gsk.com/en-gb/media/press-releases/gsk-s-5-in-1-meningococcal-abcwy-vaccine-candidate-accepted-for-regulatory-review-by-us-fda/.
Accessed February 2025.
4. NIH. Effectiveness
of GlaxoSmithKline Biologicals S.A.'s Meningococcal Group B and
Combined ABCWY Vaccines in Healthy Adolescents and Young
Adults,
ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04502693.
Accessed February 2025.
5. NIH. Immunogenicity
and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents
and Adults Previously Primed With MenACWY
Vaccine,
ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/study/NCT04707391.
Accessed February 2025.
6. Centers
for Disease Control and Prevention. Meningococcal
Vaccine Recommendations. Available
at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html. Accessed
February 2025.
7. Cheng
WY, et al. Determinants of Meningococcal ACWY vaccination in
adolescents in the US: completion and compliance with the CDC
recommendations. Hum Vaccin
Immunother.
2020;16(1):176-188.
8. Centers
for Disease Control and Prevention. National
Vaccination Coverage Among Adolescents Aged 13-17 Years - National
Immunization Survey-Teen, United States, 2023. Available
at: https://www.cdc.gov/mmwr/volumes/73/wr/mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388).
Accessed February 2025.
9. Based
on information licensed from IQVIA: IQVIA, DDD, Meningococcal B
market all channels, period January - December 2024, reflecting
estimates of real-world activity. All rights
reserved.
10. World
Health Organisation. Meningitis
fact sheet.
Available at: https://www.who.int/news-room/fact-sheets/detail/meningitis. Accessed
April 2024.
11. Thompson
MJ, et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet.
2006;367(9508):397-403.
12. Marshall
GS, et al. Understanding the Sequelae of Invasive Meningococcal
Disease in the United States. Infect Dis
Ther.
2024;13(11):2213-2220.
13. European
Centers for Disease Control and
Prevention. Outbreak
of invasive meningococcal disease in the EU associated with a mass
gathering event, the 23rd World Scout Jamboree, in
Japan. 21
August 2015. Available at: https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf.
Accessed February 2025.
14. Centers
for Disease Control and Prevention. Risk Factors
for Meningococcal Disease. Available
at: https://www.cdc.gov/meningococcal/risk-factors/index.html.
Accessed February 2025.
15. GSK.
US Prescribing Information for Penmenvy.
Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF.
Accessed February 2025.
16. GSK
Data on File. Number of
Bexsero doses shipped from 2015 to November 2023 REF-219766
17. GSK.
US Prescribing Information for Bexsero.
Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF. Accessed
February 2025.
18. GSK
Data on File. Menveo Doses
Shipped from 2010 to end of 2022 REF-195452
19. GSK.
Prescribing Information for Menveo.
Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF. Accessed
February 2025.
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: February
17, 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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