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: 13 June 2025,
London UK
GSK's RSV
vaccine, Arexvy, accepted for regulatory review by the European
Medicines Agency to expand use in adults 18 years and
older
●
Regulatory
decision anticipated H1 2026
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines
Agency (EMA) has accepted the company's regulatory application to
expand the use of its adjuvanted recombinant respiratory syncytial
virus (RSV) vaccine to include adults from 18 years of
age. Arexvy was the first RSV vaccine approved in the
European Economic Area for the prevention of lower respiratory
tract disease (LRTD) caused by RSV in adults aged 60 and older, and
for those aged 50-59 years who are at increased risk for RSV
disease.
RSV is a common contagious virus affecting the lungs and breathing
passages and impacts 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
A European regulatory decision on this submission is anticipated in
H1 2026. GSK is continuing to seek expanded indications for its RSV
vaccine in other geographies including the US and
Japan.
About GSK's RSV vaccine
Respiratory Syncytial Virus Vaccine, Adjuvanted, contains
recombinant RSV glycoprotein F stabilised in the prefusion
conformation (RSVPreF3). This antigen is combined with GSK's
proprietary AS01E adjuvant.
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 vaccine has been approved for the prevention of RSV-LRTD in
individuals 60 years of age and older in more than 60 countries. In
addition, it is approved for use in individuals aged 50-59 who are
at increased risk due to certain underlying medical conditions in
more than 50 markets, including the US, Japan and
Europe.
Please refer to the updated Product Information (PI) for important
dosage, administration, and safety information in Europe at this
link: http://www.ema.europa.eu/medicines/human//EPAR/arexvy
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 RSV in adults
RSV is a common contagious virus affecting the lungs and breathing
passages, and impacts an estimated 64 million people of all ages
globally every year.1 Adults
can be at increased risk for RSV disease due to certain
comorbidities, immune compromised status, or advanced
age.4 RSV
can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.4
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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+44 (0) 20 8047 5502
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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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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) 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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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 3126
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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
Notes:
*The European Medicines Agency reviews medicines for European Union
member states, as well as in the European Economic Area (EEA)
countries Iceland, Norway and Liechtenstein.
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. Accessed
June 2025
2.
Osei-Yeboah R, et al. Estimation of the Number of Respiratory
Syncytial Virus-Associated Hospitalizations in Adults in the
European Union. J Infect
Dis 2023
May 29;228(11):1539-1548. doi: 10.1093/infdis/jiad189
3. 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.
4.
Falsey, AR et
al.
Respiratory syncytial virus infection in elderly and high-risk
adults, in New Engl J
Med 2005;
352:1749-59. doi: 10.1056/NEJMoa043951
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
13, 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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