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 April 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:
27 April 2023, London UK
GSK's respiratory syncytial virus older adult vaccine candidate
gains positive European Medicines Agency CHMP opinion
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Positive
opinion advances GSK's goal to provide the first vaccine to help
protect older adults from respiratory syncytial virus
disease
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Opinion
is supported by data showing the vaccine candidate's exceptional
efficacy in older adults, including those with underlying medical
conditions
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Decision
on EU marketing authorisation expected by July 2023
GSK plc (LSE/NYSE:
GSK) today
announced that the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion by consensus recommending approval of GSK's respiratory
syncytial virus (RSV) vaccine candidate for the prevention of lower
respiratory tract disease (LRTD) caused by RSV in adults aged 60
years and older. This is the first time an RSV vaccine candidate
for adults has gained a positive opinion, one of the final steps in
the marketing authorisation procedure prior to approval by the
European Commission.
There are no RSV vaccines or specific treatments
currently available for older adults. RSV causes over 270,000
hospitalisations and approximately 20,000 in-hospital deaths in
adults aged 60 years and older each year in
Europe.1 If
approved, GSK's candidate has the potential to be the first vaccine
available to help protect older adults from RSV
disease.
GSK's
marketing authorisation application has been reviewed under
accelerated assessment. This applies to products determined by the
CHMP to be of major interest for public health and therapeutic
innovation. The European Commission's final decision is expected by
July 2023.
The positive opinion is supported
by data
from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase
III vaccine efficacy trial. In
the trial, the vaccine candidate showed 82.6% (96.95% CI,
57.9-94.1, 7 of 12,466 vs. 40 of 12,494) overall vaccine efficacy
against RSV-LRTD in adults aged 60 years and older, meeting the
primary endpoint. Efficacy was 94.6% (95% CI, 65.9-99.9, 1 of 4,937
vs. 18 of 4,861) in older adults with at least one underlying
medical condition of interest such as certain cardiorespiratory
and endocrino-metabolic conditions. The vaccine was generally well
tolerated with an acceptable safety profile. The most frequently
observed solicited adverse events were injection site pain,
fatigue, myalgia, headache, and arthralgia. These were generally
mild to moderate and transient.
GSK's
RSV older adult vaccine candidate is also under regulatory review
by the US Food and Drug Administration, Japan's Ministry of Health,
Labour and Welfare, and several other regulatory agencies, with
decisions expected in 2023. Additional regulatory submissions will
continue throughout this year.
About GSK's RSV older adult vaccine candidate
GSK's RSV older adult vaccine candidate contains a
recombinant subunit RSV prefusion F glycoprotein antigen (RSVPreF3)
combined with the Company's proprietary AS01E adjuvant.
Across multiple trials, the vaccine candidate was generally well
tolerated with an acceptable safety profile. The most frequently
observed solicited adverse events were injection site pain,
fatigue, myalgia, headache, and arthralgia. These were typically
mild to moderate and transient. The GSK proprietary AS01
adjuvant system contains QS-21 STIMULON adjuvant licensed from
Antigenics Inc, a wholly owned subsidiary of Agenus
Inc.
A
clinical trial that aims to expand the population who may benefit
from RSV vaccination into adults aged 50-59, including participants
with underlying comorbidities, is fully recruited. Results are
expected in 2023, together with additional results from the
AReSVi-006 phase III efficacy trial and the AReSVi-004
immunogenicity trial. These trials continue to evaluate an annual
revaccination schedule and protection/immunogenicity over multiple
seasons following one dose of the RSV vaccine candidate. Results
from two additional influenza vaccine co-administration trials are
also expected in H1 2023.
There
are currently no RSV vaccines approved anywhere in the
world.
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. Older adults are at high
risk for severe disease due in part to age-related decline in
immunity, and older adults with underlying conditions are at even
greater risk for severe disease. RSV can exacerbate other
conditions, including chronic obstructive pulmonary disease, asthma
and chronic heart failure and can lead to severe complications,
such as pneumonia, hospitalisation, and death. Each year RSV causes
over 470,000 hospitalisations and 33,000 deaths in adults aged 60
and above in high-income countries.1 Adults
with underlying conditions are more likely to seek medical services
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
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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, GSK's Q1 Results for 2023 and any impacts of the COVID-19
pandemic.
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 November 11 (Epub ahead of print). [PMID:
36369772]. Accessed February 2022. Available
at: Respiratory
syncytial virus disease burden in adults aged 60 years and older in
high‐income
countries: A systematic literature review and
meta‐analysis
- Savic - Influenza and Other Respiratory Viruses - Wiley Online
Library
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: April
27, 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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