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
●
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
GSK enquiries
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Media:
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Investor Relations:
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Nick Stone
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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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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Camilla Campbell
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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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(Philadelphia)
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Frannie DeFranco
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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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