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 December 2023
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: 12 December 2023, London UK
Japan's Ministry of Health, Labour and
Welfare accepts Arexvy regulatory application to prevent RSV
disease in adults aged 50-59 at increased risk
● Submission supported by positive results of a
Phase III study showing immune response and safety in adults aged
50-59
●
Adults
aged 50 and above with certain underlying medical conditions are at
increased risk for RSV disease
●
GSK
is the first company to seek regulatory approval to extend RSV
vaccination to this population
GSK plc (LSE/NYSE: GSK) today
announced that Japan's
Ministry of Health, Labour and Welfare (MHLW) has
accepted for review a regulatory application to extend the
indication of GSK's respiratory syncytial virus (RSV) vaccine
(recombinant adjuvanted) for the prevention of RSV disease in
adults aged 50-59 at increased risk.
This regulatory submission follows Japan's approval of GSK's
vaccine for the prevention of RSV disease in adults from the age of
60 years, and the recent announcement of 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/) of
a phase III trial [NCT05590403 https://clinicaltrials.gov/study/NCT05590403] evaluating
the immune response and safety of GSK's RSV vaccine in adults aged
50-59, including those at increased risk for RSV lower
respiratory tract disease (LRTD) due to certain underlying medical
conditions.
The burden of RSV disease in adults is likely to be underestimated
due to lack of awareness and standardised testing, as well as
under-detection within surveillance studies[1],
but people with underlying medical conditions - such as chronic
obstructive pulmonary disease (COPD), asthma, chronic heart
failure
[2] and
diabetes[3]-
are at increased risk for RSV disease. RSV can exacerbate these
conditions and lead to pneumonia, hospitalisation, or
death.[4] An
international systematic review of the prevalence of respiratory
viruses in patients with acute exacerbations of COPD, for example,
showed that RSV was detected 1 in 10 cases.[5]
GSK is the first company to seek regulatory approval to extend RSV
vaccination to help protect adults aged 50 to 59 at increased risk
for RSV disease. Further announcements on regulatory progress in
the US and EU are expected in early 2024.
About Arexvy
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 MHLW has approved GSK's RSV vaccine for the prevention of RSV
(respiratory syncytial virus) disease for adults aged 60 years and
above. 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, Europe, 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. 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
have been presented at the US Centers for Disease Control and
Prevention's (CDC) Advisory Committee on Immunization Practices
(ACIP) meeting on 25 October 2023 and 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
age4.
RSV can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death4. Each
year, RSV causes approximatively 470,000 hospitalisations and
33,000 in-hospital deaths in adults 60 years of age and older in
industrialised countries, including approximately 63,000
hospitalisations and 4,500 deaths in Japan1.
Adults with underlying conditions are more likely to seek medical
advice and have higher hospitalisation rates than adults without
these conditions[6].
Please refer to the updated Product Information (PI) for important
dosage, administration, and safety information in Japan at this
link: https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html
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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Investor
Relations:
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Nick
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(London)
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James
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+44 (0)
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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)
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Jeff
McLaughlin
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751 7002
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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] 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
[2] Falsey,
AR et
al. Respiratory
syncytial virus infection in elderly and high-risk adults,
in New Engl J
Med 2005;
352:1749-59
[3] Richard
Osei-Yeboah et
al,
Respiratory syncytial virus-associated hospitalisation in adults
with comorbidities in two European countries, PROMISE
investigators, preprint, August 2023
[4] Centers
for Disease Control and Prevention (CDC), RSV in Older Adults and
Adults with Chronic Medical Conditions, 2023
[5] Zwaans
WA et
al., The
relevance of respiratory viral infections in the exacerbations of
chronic obstructive pulmonary disease-A systematic review,
in J Clin
Virol 2014;61:181-188
[6] Branche
AR et
al. Incidence
of Respiratory Syncytial Virus Infection Among Hospitalized Adults,
2017-2020, Clin Infect
Dis 2022;74:1004-1011
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: December
12, 2023
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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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