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 November 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: 22 November 2024, London UK
Arexvy approval
expanded to adults aged 50-59 at increased risk of severe RSV
disease in Japan
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First
RSV vaccine approved in Japan to help protect 50-59 year olds at
increased risk due to certain underlying health
conditions
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RSV
infections can exacerbate these underlying health conditions and
lead to severe outcomes, such as pneumonia, hospitalisation and
death1
●
35
countries, including the US, have expanded approval for GSK's RSV
vaccine in this at increased risk population
GSK plc (LSE/NYSE: GSK) today
announced that Japan's
Ministry of Health, Labour and Welfare (MHLW) has
approved a regulatory application to extend the indication
of Arexvy (respiratory
syncytial virus vaccine, recombinant adjuvanted) for
the prevention of RSV disease to include adults aged 50-59 at
increased risk. Since
September 2023, GSK's RSV vaccine has been approved in Japan for
adults aged 60 and over for the prevention of RSV
disease.2
Tony Wood, Chief Scientific Officer at GSK, said: "This
approval reflects our ambition to protect people at increased risk
from the severe consequences of RSV infection. Adults aged 50-59
with certain underlying medical conditions can face debilitating
consequences from RSV, so we are pleased to offer those in Japan a
vaccine for the first time."
RSV is a common contagious virus affecting the lungs and breathing
passages and
it impacts an estimated 64 million people of all ages globally
every year.3 Adults
can be at increased risk for RSV disease due to certain underlying
medical conditions, immune compromised status, or advanced
age.1 RSV
infection can exacerbate conditions, including COPD, asthma, and
chronic heart failure and can lead to severe outcomes, such as
pneumonia, hospitalisation, and death.1
This regulatory expansion was supported by results
from a global phase III trial (including 4 clinical sites in Japan)
that showed non-inferior immunogenicity in adults aged 50-59 at
increased risk of RSV lower respiratory tract disease compared to
those aged 60 and older.4 Safety
and reactogenicity in the 50-59 at increased risk population were
consistent with results from the initial phase III programme in
adults aged 60 and older. 4
To date, GSK's RSV vaccine has been approved for adults aged 50-59
at increased risk in 35 countries, including the US, with
regulatory decisions for other geographies undergoing review.
About GSK's RSV vaccine
Respiratory Syncytial Virus Vaccine, Adjuvanted recombinant,
contains recombinant RSV glycoprotein F stabilised in the prefusion
conformation (RSVPreF3). This antigen is combined with GSK's
proprietary AS01E adjuvant.
In September 2023, the MHLW approved GSK's RSV vaccine for the
prevention of RSV (respiratory syncytial virus) disease for adults
aged 60 years and above in Japan. The use of this vaccine should be
in accordance with official recommendations. As with any vaccine, a
protective immune response may not be elicited in all
vaccinees.
The Arexvy Product
Information, including a full list of adverse events and the
complete important safety information in Japan, will be
available from
the Japan Pharmaceuticals and Medical Devices
Agency.
The GSK proprietary AS01 adjuvant system contains STIMULON QS-21
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of
Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary
of Agenus.
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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(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. Centers
for Disease Control and Prevention (CDC), RSV in
Adults. Available
at: https://www.cdc.gov/rsv/older-adults/index.html -
accessed in November 2024
2.
Package insert in Japanese of Arexvy Intramuscular Injection,
Revised Oct 2024 2nd edition,
Available at: https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/340278_631341NE1021_1_03 -
accessed in November 2024
3. National
Institute of Allergy and Infectious Diseases, Respiratory Syncytial
Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv -
last accessed: November 2024
4. Ferguson,
M. et al., "Noninferior Immunogenicity and Consistent Safety of
Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults
50-59 Years Compared to ≥60 Years of Age"
in Clinical Infectious
Diseases,
2024; 79(4): 1074 . doi.org/10.1093/cid/ciae364
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: November
22, 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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