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 November 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: 2 November 2022, London UK
GSK's respiratory syncytial virus older adult vaccine candidate
granted Priority Review by US FDA
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US FDA
has set a Prescription Drug User Fee Act action date of 3 May
2023
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This is the third major regulatory milestone for the vaccine
candidate following acceptance of regulatory submissions in Europe
and Japan
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Vaccine candidate has the potential to be the first available to
help protect adults aged 60 years and older from lower respiratory
tract disease caused by respiratory syncytial virus
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GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted a Biologics License Application
(BLA) and granted Priority Review for its respiratory syncytial
virus (RSV) older adult vaccine candidate.
The US FDA grants Priority Review to applications for vaccines
that, if approved, would offer significant improvements in the
safety or effectiveness of the treatment or prevention of serious
conditions when compared to standard applications. A Priority
Review designation means the US FDA's goal is to expedite review of
a BLA, reducing the review period by four months. The Prescription
Drug User Fee Act date, the FDA action date for their regulatory
decision, is 3 May 2023. If approved, GSK's RSV older adult vaccine
candidate has the potential to be the first vaccine available to
help protect adults aged 60 years and older from lower respiratory
tract disease caused by RSV infection.
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.
The BLA 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 lower respiratory tract disease (LRTD)
in adults aged 60 years and older. The vaccine was well tolerated
with a favourable safety profile. The most frequent observed
solicited adverse events were injection site pain, fatigue,
myalgia, and headache. 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.
This is the third major regulatory milestone for GSK's RSV older
adult vaccine candidate following regulatory submission acceptances
by the European Medicines Agency and Japan's Ministry of Health,
Labour and Welfare. 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 older 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 older adult investigational vaccine in adults aged 60
years and above. Approximately 25,000 participants were enrolled
from 17 countries.
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. It is one of the major remaining infectious diseases for
which there is currently no vaccine or specific treatment available
for adults. In
adults, RSV infection is typically mild, but may lead to severe
outcomes. Older
adults are at high risk for severe disease due to age-related
decline in immunity and underlying conditions. RSV can exacerbate
conditions, including 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 aged 60 years and older in industrialised
countries, including
approximately 177,000 and 14,000, respectively in the US. 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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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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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
when issued GSK's Q3 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: November
02, 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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