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 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')
Issued: 29 July 2024, London UK
Arexvy, GSK's Respiratory Syncytial Virus (RSV) vaccine,
receives positive European Medicines Agency CHMP opinion for adults
aged 50-59 at increased risk for RSV disease
●
If approved, this will be the first vaccine in the EU for adults
aged 50-59 who are at increased risk of respiratory syncytial virus
disease
●
Decision on EU marketing authorisation for this population expected
by September 2024
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) has
recommended expanding the approval of GSK's respiratory syncytial
virus (RSV) vaccine for the prevention of lower respiratory tract
disease (LRTD) caused by RSV from adults aged 60 and above to
include adults aged 50-59 years at increased risk for RSV disease.
Today's positive opinion is the first time that an indication
for adults aged 50-59 has been recommended by CHMP for a RSV
vaccine, one of the final steps prior to the extension of the
marketing authorisation by the European Commission. The
European Commission's final decision is expected by September
2024. Since June 2023, Arexvy (respiratory syncytial virus vaccine,
recombinant adjuvanted) has been approved in Europe for adults
aged 60 and over for the prevention of
RSV-LRTD.
Adults with underlying medical conditions, such as chronic
obstructive pulmonary disease (COPD), asthma, heart
failure[1] and
diabetes
[2] are
at increased risk for severe consequences from an RSV infection
compared to those without these conditions. RSV can exacerbate
these conditions and lead to pneumonia, hospitalisation or
death.1
Each year, RSV causes approximately 270,000 hospitalisations and
20,000 in-hospital deaths in adults 60 years of age and older in
Europe.[3] The
burden of RSV disease in at increased risk adults aged 50-59 is
similar to that of the overall population aged 60 and
above.[4]
The positive opinion is supported by results from a phase III trial
[NCT05590403][5] 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.
GSK's RSV vaccine was approved by the US FDA for adults aged 50-59
at increased risk on 7 June 2024. GSK has also filed regulatory
submissions to expand the use of its RSV vaccine to adults aged
50-59 at increased risk 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 due to certain underlying medical conditions and in
immunocompromised adults aged 18 and over are expected to read out
in H2 2024.
About GSK's RSV Vaccine
Respiratory Syncytial Virus Vaccine, recombinant,
adjuvanted, contains recombinant RSV glycoprotein F stabilised in
the prefusion conformation (RSVPreF3). This antigen is combined
with GSK's proprietary AS01E adjuvant.
The vaccine was approved in Europe for adults aged 60 and over for
the prevention of RSV-LRTD in June 2023. 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 also been approved for the prevention of RSV-LRTD
in individuals 60 years of age and older in over 45 countries,
including the 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 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 older adults
RSV is a common contagious virus affecting the
lungs and breathing passages. Adults can be at increased risk for
RSV disease due to comorbidities, immune compromised status, or
advanced age. RSV can exacerbate conditions, including COPD,
asthma, and chronic heart failure and can lead to severe outcomes,
such as pneumonia, hospitalisation, and death.1 Each
year RSV causes approximatively 470,000 hospitalisations and 33,000
deaths in adults aged 60 and older in high-income
countries.3
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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Investor Relations:
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(London)
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James Dodwell
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Steph Mountifield
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+44 (0) 7736 063933
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Jeff McLaughlin
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(Philadelphia)
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Frannie DeFranco
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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 Q1
Results for 2024.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford, Middlesex
TW8 9GS
References
[1] Centers for Disease
Control and Prevention (CDC), RSV in Adults, 2024 - available:
https://www.cdc.gov/rsv/older-adults/index.html
[2] Branche AR et al.,
« Incidence of Respiratory Syncytial Virus Infection
Among Hospitalized Adults, 2017-2020" in Clinical Infectious
Diseases, 2022:74:1004-1011
[3] Savic M, Penders Y,
Shi T, Branche A, Pirçon J-Y. Respiratory syncytial virus
disease burden in adults aged 60 years and older in high-income
countries: a systematic literature review and meta-analysis,
in Influenza Other Respir
Viruses 2022 2023;
17:e13031
[4] McClure DL et al.
Seasonal incidence of medically attended respiratory syncytial
virus infection in a community cohort of adults >50 years old.
PLoS One 2014; 9(7): e102586.
[5] ClinicalTrials.gov, A
Study on the Immune Response and Safety of a Vaccine Against
Respiratory Syncytial Virus Given to Adults 50-59 Years of Age,
Including Adults at Increased Risk of Respiratory Syncytial Virus
Lower Respiratory Tract Disease, Compared to Older Adults 60 Years
of Age and Above 2023. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403
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
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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