Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
October 21 2022 - 12:31PM
Edgar (US Regulatory)
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 October 2022
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 . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
Issued: 21 October 2022, London UK
GSK regulatory submission accepted by Japanese regulator for
respiratory syncytial virus older adult vaccine
candidate
●
Regulatory submission based on
positive pivotal phase III data showing vaccine
efficacy against respiratory
syncytial virus-lower respiratory tract disease in
adults aged 60 years and above with a favourable safety
profile
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Further
announcements on regulatory progress in the US and EU are expected
in Q4 2022
GSK plc (LSE/NYSE: GSK) today announced that a new drug application
for its respiratory syncytial virus (RSV) older adult vaccine
candidate has been accepted for review by the Japanese Ministry of
Health, Labour and Welfare (MHLW). The proposed indication is for
adults aged 60 years and above to prevent lower respiratory tract
diseases (LRTD) caused by RSV.
The filing is based on positive data from a prespecified interim
analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial which showed high overall
vaccine efficacy against RSV-LRTD in adults aged 60 years and
above, with a favourable safety profile. Consistent high vaccine
efficacy was observed against LRTD in severe disease, adults aged
70-79 years, adults with underlying comorbidities and across RSV A
and B strains.
Further announcements on regulatory progress in the US and EU are
anticipated before the end of 2022. GSK's
RSV older adult vaccine candidate contains a recombinant subunit
prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's
proprietary AS01E adjuvant. There
are currently no RSV vaccines for adults approved anywhere in the
world.
About the AReSVi-006 trial
The
AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomised,
placebo-controlled, observer-blind, multi-country trial to
demonstrate the efficacy of a single dose of GSK's adjuvanted
RSVPreF3 OA investigational vaccine in adults aged 60 years and
above. Approximately 25,000 participants were enrolled from 17
countries.
About respiratory syncytial virus (RSV) in adults
RSV is a common contagious virus affecting the lungs and breathing
passages. It is one of the major remaining infectious diseases for
which there is currently no vaccine or specific treatment available
for adults. Older adults are at high risk for severe disease due to
age-related decline in immunity and underlying conditions. RSV can
exacerbate conditions, including chronic obstructive pulmonary
disease (COPD), asthma and chronic heart failure and can lead to
severe outcomes, such as pneumonia, hospitalisation, and death.
Each year, RSV causes over 420,000 hospitalisations and 29,000
deaths in adults in industrialised countries, including
approximately 57,000 and 4,000, respectively in Japan. Adults with
underlying conditions are more likely to seek medical advice and
have higher hospitalisation rates than adults without these
conditions.
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/company
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GSK enquiries
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Media:
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Tim
Foley
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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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Lyndsay
Meyer
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+1 202
302 4595
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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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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 in the Company's
Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
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: October
21, 2022
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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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