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 January 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 . . . . . . . .
Issued: 29 January 2024, London UK
GSK's RSV
vaccine, Arexvy, accepted for regulatory review by the
European Medicines Agency for the prevention of RSV disease in
adults aged 50-59 at increased risk
●
Application supported by positive
results of a Phase III study showing
immune response and acceptable tolerability profile in this
population
●
Adults aged 50 and above with
underlying medical conditions are at increased risk for RSV
disease[1]
●
GSK
is the first company to file for regulatory approval to extend RSV
vaccination to adults aged 50-59 at increased risk
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 adults aged 50-59 who are at increased risk for RSV
disease. If accepted, GSK's RSV vaccine would be the first vaccine
available to help protect this population. Arexvy is
currently approved in Europe in adults aged 60 and over for the
prevention of lower respiratory tract disease (LRTD) caused by
RSV.
This regulatory submission follows the positive
results (https://www.gsk.com/en-gb/media/press-releases/new-data-for-arexvy-show-potential-to-help-protect-adults-aged-50-to-59/) from
a phase III trial [NCT05590403][2] 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 underlying medical conditions.
The burden of RSV disease in adults is likely to be underestimated
due to lack of awareness, lack of standardised testing, and
under-detection in surveillance studies.[3] People
with underlying medical conditions, such as chronic obstructive
pulmonary disease (COPD), asthma, chronic heart
failure[4] and
diabetes[5] are
at increased risk for RSV disease. RSV can exacerbate these
conditions and lead to pneumonia, hospitalisation, or
death[6]. The
burden in adults aged 50-59 and at increased risk for RSV disease
is similar to that of 60 and above[7].
GSK is the first company to file for regulatory approval to extend
RSV vaccination to help protect adults aged 50 to 59 at increased
risk for RSV disease due to underlying medical conditions. A
European regulatory decision is anticipated in Q3
2024.
About GSK's RSV vaccine
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 European Medicines Agency 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. 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 lower
respiratory tract disease (LRTD) caused by RSV in individuals 60
years of age and older in the US, Japan, UK, Canada and several
other countries. 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 the NCT05590403 trial
NCT05590403 is a phase III, placebo-controlled, observer-blind,
randomized, multi-country immunogenicity trial to evaluate the
non-inferiority of the immune response and evaluate safety in
participants aged 50 to 59 at increased risk of RSV-LRTD compared
to older adults aged 60 years and above after a single dose of
GSK's RSV vaccine.
The study assessed the immune response in participants aged 50 to
59 with pre-defined stable chronic diseases leading to an increased
risk of RSV disease (n=570). Immune responses in a broader group of
participants aged 50-59 years without these pre-defined chronic
diseases (n=570) were also evaluated compared to adults aged 60 and
older. The trial's primary endpoints were RSV-A and RSV-B
neutralisation titres of both groups of 50 to 59 year olds at one
month after the vaccine administration compared to adults aged 60
and older. Primary endpoints were met with
non-inferior immune responses observed in adults aged 50-59
compared to adults aged 60 and older. There were also safety
and immunogenicity secondary and tertiary
endpoints.
Results from this trial will be presented at upcoming medical
conferences and submitted for peer-reviewed publication. The data
are being submitted to other regulators to support potential label
expansions.
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
comorbidities, 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 Each
year, RSV causes approximately 270,000 hospitalisations and 20,000
in-hospital deaths in adults 60 years of age and older in
Europe.4
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.
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)
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(London)
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Simon
Moore
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+44 (0)
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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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Nick
Stone
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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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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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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 under Item 3.D
'Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q3 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1] Malosh,
2017; Prasad, 2021, Begley, 2023. National
Library of Medicine, Respiratory Syncytial Virus hospitalisation in
middle-aged and older adults
[2] National
Library of Medicine, [Study Details | 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 |
ClinicalTrials.gov]
[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, Influenza
Other Respir Viruses 2022 2023;
17:e13031
[4] Falsey,
AR et
al. Respiratory
syncytial virus infection in elderly and high-risk adults,
in New Engl J
Med 2005;
352:1749-59
[5] Richard
Osei-Yeboah et
al,
Respiratory syncytial virus-associated hospitalisation in adults
with comorbidities in two European countries, PROMISE
investigators, preprint, August 2023
[6] Centers
for Disease Control and Prevention (CDC), RSV in Older
Adults and Adults with Chronic Medical
Conditions,
2023
[7] McClure et
al. 2014.
National Library of Medicine: Seasonal incidence of medically
attended respiratory syncytial virus infection in a community
cohort of adults >50 years old
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: January
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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