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 June 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: 20th June 2025, London UK
Japan's Ministry of Health, Labour and
Welfare accepts regulatory application to expand use of GSK's RSV
vaccine, Arexvy, in adults aged 18-49 at increased risk of
severe RSV disease.
●
If
approved, GSK's RSV vaccine would be the first available in Japan
to help protect this group
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Submission
supported by positive Phase IIIb data showing immune response and
safety in this population
GSK plc (LSE/NYSE: GSK) today
announced that Japan's
Ministry of Health, Labour and Welfare (MHLW) has
accepted the company's regulatory application to expand the use of
its adjuvanted recombinant respiratory syncytial virus (RSV)
vaccine to include adults aged 18-49 at increased risk of severe
RSV disease. Arexvy was
the first vaccine approved in Japan for adults aged 60 years and
older for the prevention of RSV disease, and for those aged 50
years and older at increased risk for severe RSV
disease.
RSV is a common, contagious virus affecting the lungs and breathing
passages impacting an estimated 64 million people of all ages
globally every year.[1] RSV
can exacerbate certain medical conditions, and lead to severe
illness resulting in hospitalisation and even death[2],[3],[4].
This regulatory submission is supported by positive results from
phase IIIb trial NCT06389487[5] which
showed a non-inferior immune response in adults
aged 18-49 at increased risk for RSV-LRTD due to certain underlying
medical conditions, to that observed in adults aged 60 and above.
The safety and reactogenicity data were consistent with results
from the phase III programme that supported the initial approval of
the vaccine in Japan.
GSK is the first company to seek regulatory approval for the
vaccine to help protect adults aged 18-49 at increased risk of
severe RSV disease in Japan. Regulatory submissions to expand the
indications for the RSV vaccine continue in other geographies
including the US and Europe.
About Arexvy
Respiratory syncytial virus vaccine, adjuvanted, contains
recombinant glycoprotein F stabilised in the prefusion conformation
(RSVPreF3). This antigen is combined with GSK's proprietary
AS01E adjuvant.
The MHLW has approved GSK's RSV vaccine for the prevention of RSV
(respiratory syncytial virus) disease for adults aged 60 years and
above and adults aged 50 and older who are considered at increased
risk of severe RSV disease. 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 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 the NCT06389487 trial
NCT06389487 is a phase IIIb open-label study to evaluate the
non-inferiority of the immune response and to evaluate the safety
of GSK's RSV vaccine in adults aged 18-49 at increased risk for RSV
disease (n=426) compared to adults aged 60 and older (n=429). An
additional cohort of 603 participants aged 18-49 were followed up
for adverse events separate to safety follow up of the initial
cohort. 1,458 participants were enrolled across 52 locations in 6
countries, including 4 sites in Japan.
The trial's co-primary endpoints were RSV-A and RSV-B
neutralisation titers expressed as mean geometric titer ratio
(relative to older adults over adults at increased risk) and
sero-response rate in RSV-A and RSV-B neutralising titers one month
post vaccine administration. There were also safety and
immunogenicity secondary endpoints.
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing
passages. RSV impacts an estimated 64 million people of all ages
globally every year.1 Adults
can be at increased risk for RSV disease due to comorbidities,
immune compromised status, or advanced age.2 RSV
can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.2
Please refer to the updated Product Information (PI) for important
dosage, administration, and safety information in Japan at this
link: https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html
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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(London)
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Kathleen
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603 5003
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(Washington
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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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Constantin
Fest
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+44 (0)
7831 826525
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(London)
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James
Dodwell
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+44 (0)
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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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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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.
Registered in England & Wales:
No.
3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
[1] 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: June 2025
[2] Falsey,
AR et
al.
Respiratory syncytial virus infection in elderly and high-risk
adults, in New
Engl J Med 2005;
352:1749-59
[3] Osei-Yeboah,
R et al. Respiratory Syncytial Virus-Associated Hospitalization in
Adults with Comorbidities in 2 European Countries: A Modeling
Study. J Infect Dis; 2024; 229 (suppl 1):
S70-S77
[4] Atamna
A, Babich T, Froimovici D, Yahav D, Sorek N, Ben-Zvi H, Leibovici
L, Bishara J, Avni T. Morbidity and mortality of respiratory
syncytial virus infection in hospitalized adults: Comparison with
seasonal influenza. Int J Infect Dis. 2021 Feb;103:489-493. doi:
10.1016/j.ijid.2020.11.185.
[5] Clinicaltrials.gov,
"A Study on the Immune Response and Safety of Vaccine Against
Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of
Age at Increased Risk for Respiratory Syncytial Virus Disease,
Compared to Older Adults 60 Years of Age and Above" - available
at: https://clinicaltrials.gov/study/NCT06389487
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: June
20, 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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