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 July 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: 14 July 2025, London UK
US FDA accepts application to review expanded use of GSK's RSV
vaccine, Arexvy, for adults 18-49 at increased risk
●
More
than 21 million US adults under the age of 50 have at least one
risk factor for severe RSV infection1
● Submission supported by positive Phase IIIb data
showing immune response and safety results in this
population
● FDA decision anticipated H1
2026
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has
accepted for review an application to extend the indication
of Arexvy (respiratory
syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who
are at increased risk. GSK's RSV vaccine is approved in the US
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.
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.2 More
than 125 million adults in the US are under 50 years of
age.1 An
estimated 21 million of these people have at least one diagnosed
risk factor for severe RSV infection, such as chronic obstructive
pulmonary disease (COPD), asthma, congestive heart failure and
coronary heart disease (CHD).1 RSV
can exacerbate certain medical conditions and can also lead to
severe illness resulting in hospitalisation, and even
death.3 4
5
This regulatory submission is supported by a phase IIIb trial
evaluating immune response and safety in adults aged 18-49 at
increased risk compared to adults aged 60 and
above.6 The
safety and reactogenicity data were consistent with results from
the phase III programme that supported the initial approval of the
vaccine in the US.
A regulatory decision by the FDA on this submission is expected in
H1 2026.
GSK is continuing to seek expanded indications for its RSV vaccine
in other geographies including in the European Economic Area 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 FDA has approved GSK's RSV vaccine for the prevention of lower
respiratory tract disease (LRTD) caused by respiratory syncytial
virus (RSV) in individuals 60 years of age and older, and those
aged 50-59 who are at increased risk. 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 in more than 50 markets, including the US, Japan
and Europe.
Please refer to the full US Prescribing Information (PI) for
important dosage, administration, and safety
information: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
The AS01 adjuvant system, owned by GSK, includes the QS-21
adjuvant, licensed by Antigenics, a wholly owned 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 16 US sites.
The trial's co-primary endpoints were RSV-A and RSV-B
neutralisation titres expressed as geometric mean titre ratio
(relative to older adults over adults at increased risk) and
seroresponse rate in RSV-A and RSV-B neutralising titres 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 and impacts an estimated 64 million people of all ages
globally every year.2 Adults
can be at increased risk for RSV disease due to certain
comorbidities, immune compromised status, or advanced
age.5 RSV
can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.5
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.
GSK enquiries
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Media:
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Simon Steel
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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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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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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
Note:
Among adults aged 20-49 years in the US, a total of 17.0% (N=21
million/125 million) had at least one diagnosed risk factor for
severe RSV disease (including congestive heart failure, coronary
heart disease, stroke, angina, myocardial infarction, chronic
obstructive pulmonary disease , current asthma, diabetes, current
liver disease, and/or renal disease)
References:
1. E.Horn
et al, "Characteristics Associated with the Presence of One or More
Risk Factors for Severe Respiratory Syncytial Virus Disease among
Adults in the United States", poster presented at ID Week 2024
[available on demand: P691 - DV-009542.pdf]
2.
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
3. McLaughlin
JM, Khan F, Begier E, et al. Rates
of Medically Attended RSV Among US Adults: A Systematic Review and
Meta-analysis. Open Forum
Infect Dis.
4. Atamna
A, Babich T, et al. 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.
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
6.
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: July
14, 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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