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 August 2024
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(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 . . . . . . . .
GSK plc (the
'Company')
Transaction notification
Issued: 29 August 2024, London UK
European Commission approves expanded
age indication for GSK's Arexvy, the first respiratory syncytial virus (RSV)
vaccine for adults aged 50-59 at increased risk
● An
estimated 20 million adults aged 50-59 in 30
European countries* have
a medical condition that increases their risk for RSV
disease1-3
● Authorisation
helps protect this population for the first time ahead of this RSV
season
● This
follows approval in US, with other countries anticipated, including
Japan later this year
GSK plc (LSE/NYSE: GSK) today announced that the European
Commission has authorised Arexvy (respiratory syncytial virus vaccine,
recombinant adjuvanted) for active immunisation for the prevention
of lower respiratory tract disease (LRTD) caused by respiratory
syncytial virus (RSV) in adults aged 50-59 who are at increased
risk. Since June 2023, GSK's RSV vaccine has been approved in
Europe for adults aged 60 and over for the prevention of
RSV-LRTD4.
Adults with underlying medical conditions, such as chronic
obstructive pulmonary disease (COPD), asthma, heart failure and
diabetes are at increased risk for severe consequences from an RSV
infection compared to those without these
conditions5,6.
RSV can exacerbate these conditions and lead to pneumonia,
hospitalisation or death.6
It is estimated that there are about 65 million adults aged between
50 and 59 in the European Union/European Economic
Area1,
with an estimated 20 million of these people (one-third) having at
least one underlying medical condition that puts them at increased
risk for RSV disease.2,3
Tony Wood, Chief Scientific Officer, GSK, said: "Today's approval reflects the
importance of broadening the benefits of RSV immunisation to adults
aged 50-59 who are at increased risk. RSV
infection can have a significant impact on the health of older
adults and particularly those with certain existing medical
conditions, which can add pressure onto healthcare
systems. As
we enter the RSV season, we are pleased to be the first to deliver
a vaccine to help protect more people in Europe from
RSV-LRTD."
The regulatory application was supported by positive results from a
phase III trial evaluating the immune response and safety of GSK's
RSV vaccine in adults aged 50-59, including those at increased risk
for RSV-LRTD due to certain underlying medical
conditions.7
Prof. Dr. Tino F. Schwarz, Klinikum Würzburg Mitte,
Würzburg, Germany said: "There are a great number of patients in the
age-group 50-59 years living with certain underlying medical
conditions with an increased risk for severe RSV infection. These
patients are likely to benefit from the extension of the age
indication of the RSV vaccine, helping to reduce the burden of
disease of RSV associated LRTDs. I hope that the NITAGs in Europe
will rapidly adapt the indication of RSV vaccination to include
these patients".
In addition to the US and European approvals, GSK has also filed
regulatory submissions to extend the use of this vaccine to adults
aged 50-59 at increased risk, including in Japan and other
geographies with regulatory decisions undergoing review. Trials
evaluating the immunogenicity and safety of the vaccine in adults
aged 18-49 at increased risk and immunocompromised adults aged 18
and over are expected to read out in later in 2024.
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 June 2023, the European Commission 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. 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 EMA Reference Information, including a full list of
adverse events and the complete important safety information in the
EU, will be available at this link: www.ema.europa.eu/medicines/human//EPAR/arexvy
The vaccine has also been approved for the prevention of RSV-LRTD
in individuals 60 years of age and older in 50 countries, including
Europe, Japan and US. Regulatory reviews in multiple countries are
ongoing. The proposed trade name remains subject to regulatory
approval in other markets.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of
Agenus Inc.
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing
passages. Adults can be at increased risk for RSV disease due to
certain underlying medical conditions, immune compromised status,
or advanced age.6 RSV
can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.6
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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Media:
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+1 540 742 3391
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(Washington DC)
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Investor Relations:
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+44 (0) 7717 618834
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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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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 Q2 Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
Notes:
*estimated from the % of individuals aged 50-59 in
France, Italy and Spain with at least one chronic
condition3 extrapolated
to the EU/EEA population of 50-59 years in 2024.1 The
European Commission has the authority to approve medicines for the
European Union member states, as well as in the European Economic
Area (EEA) countries Iceland, Norway and
Liechtenstein.
References
1. United Nations. World
Population Prospects 2024. Available at: https://population.un.org/wpp/ -
accessed in August 2024
2. Zimmerman, RK et al.,
"Prevalence of high-risk indications for influenza vaccine varies
by age, race, and income" in Vaccine,
28(39), 6470-6477.3, 2010
3. de Fougerolles, TR. et al,
"Public health and economic benefits of seasonal influenza
vaccination in risk groups in France, Italy, Spain and the UK:
state of play and perspectives" in BMC Public
Health, 24(1),
1222, 2024
4. Arexvy |
European Medicines Agency (EMA). (n.d.). European Medicines
Agency (EMA). Available
at: https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy. Accessed
August 2024 -
accessed in August 2024
5. Branche AR et al., "Incidence
of Respiratory Syncytial Virus Infection Among Hospitalized Adults,
2017-2020" in Clinical
Infectious Diseases, 74:1004-1011,
2022
6. Centers for Disease Control
and Prevention (CDC), RSV in Adults. Available
at: https://www.cdc.gov/rsv/older-adults/index.html -
accessed in August 2024
7. 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,
ciae364, 2024. Advance online publication.
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: August
29,2024
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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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