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 June 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: 7 June 2023, London UK
European Commission authorises
GSK's Arexvy, the first respiratory syncytial virus (RSV)
vaccine for older adults
●
Authorisation
will help protect adults 60 years of age and older in 30 European
countries* from RSV disease for the first time
●
In
Europe, RSV leads to over 270,000 hospitalisations and
approximately 20,000 in-hospital deaths in adults 60 years of age
and older each year
●
The
authorisation is based on phase III efficacy data in older
adults
GSK plc (LSE/NYSE: GSK) today announced that the European
Commission has authorised Arexvy (respiratory syncytial virus vaccine,
adjuvanted) for active immunisation for the prevention of lower
respiratory tract disease (LRTD) caused by respiratory syncytial
virus (RSV) in adults 60 years of age and older. This is the first
time an RSV vaccine for older adults has been granted European
Marketing Authorisation. The first launches are planned ahead of
the 2023/2024 RSV season which typically starts in the
autumn.
Tony Wood, Chief Scientific Officer, GSK, said: "Thousands
of older adults across Europe suffer serious respiratory illness
due to RSV each year. This authorisation
for Arexvy means
eligible adults can be vaccinated against RSV disease for the first
time, reinforcing GSK's long history of vaccine innovation. Our
strong manufacturing capability and scale, including from our
vaccine manufacturing site in Belgium, means we are ready to
deliver the vaccine as countries begin to
launch."
RSV is a common, contagious respiratory virus that leads to over
270,000 hospitalisations and approximately 20,000 in-hospital
deaths each year in adults aged 60 years and over in
Europe1.
An estimated 3 million cases of RSV acute respiratory infection
(ARI) are reported in this population each year, and the impact on
healthcare systems is expected to increase as the population
ages1.
Those with underlying medical conditions, such as diabetes and
chronic heart and lung disease, drive the majority of RSV
hospitalisations.2,3
Dr Alberto Papi, Full Professor of Respiratory Medicine and Head at
the University of Ferrara, said: "For
most, RSV causes cold-like symptoms. For older adults and those
with underlying medical conditions however, it can lead to severe
disease and is a leading cause of serious respiratory infections.
As scientists, we have been trying to find a solution for over 60
years. I am proud to have been part of the innovation that has
resulted in a vaccine now being available to help protect eligible
older adults across Europe from severe RSV disease for the first
time."
The authorisation is based on GSK's landmark positive pivotal
AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial
data. In the trial, the vaccine showed statistically significant
and clinically meaningful overall efficacy of 82.6% (96.95% CI,
57.9-94.1, 7 of 12,466 vs 40 of 12,494) against RSV-LRTD in adults
aged 60 years and older, meeting the primary endpoint. In addition,
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 endocrine-metabolic conditions.
The vaccine was generally well tolerated. The most frequently
observed solicited adverse events were injection site pain,
fatigue, myalgia, headache, and arthralgia. These were generally
mild to moderate and transient.
The European Commission's decision follows the European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP)
positive opinion in April 2023. GSK's marketing authorisation
application was reviewed under the accelerated assessment mechanism
because prevention of RSV disease in the older adult population is
considered a major public health interest.
Arexvy was the world's first RSV vaccine
to be approved for older adults when, in May 2023, it was approved
by the US Food and Drug Administration. Later this month, the
Advisory Committee on Immunization Practices (ACIP) will make
recommendations on the appropriate use of the vaccine in the US.
Regulatory reviews are ongoing in Japan and several other
countries.
About Arexvy (Respiratory Syncytial Virus (RSV) vaccine
(recombinant, adjuvanted))
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.
Indication
The European Commission has authorised Arexvy for active immunisation for the prevention of LRTD
caused by RSV in adults aged 60 years and older. It is also
approved in the US. 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 is not approved anywhere else in the world. The
proposed trade name remains subject to regulatory approval in other
markets.
The Arexvy EMA Reference Information, including a full
list of adverse events and the complete important safety
information in the EU, will shortly be available at this link:
www.ema.europa.eu/medicines/human//EPAR/arexvy
A clinical trial investigating RSV vaccination in 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.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of
Agenus Inc.
About AReSVi-006
This is a randomised, placebo-controlled, observer-blind,
multi-country phase III trial to demonstrate the efficacy of a
single dose of GSK's adjuvanted RSVPreF3 vaccine in adults aged 60
years and above. Approximately 25,000 participants were enrolled
from 17 countries. Initial results were published in
the New
England Journal of Medicine in
February 2023.
About RSV in older adults
RSV is a common contagious virus affecting the lungs and breathing
passages. Older adults are at high risk for severe disease due in
part to age-related decline in immunity. Older adults with
underlying medical conditions are at even greater risk for severe
disease. 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. In Europe, RSV leads to over 270,000
hospitalisation and approximately 20,000 in-hospital deaths each
year in adults aged 60 years and over 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.
GSK enquiries
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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
Notes
* The
European Commission has the authority to approve medicines for
European Union member states, as well as in the European Economic
Area (EEA) countries Iceland, Norway and
Liechtenstein.
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.
Available
at:
https://onlinelibrary.wiley.com/doi/full/10.1111/irv.13031
2.
Centers
for Disease Control and Prevention. RSV in Older Adults and Adults
with Chronic Medical Conditions. Accessed March 2023.
Available
at: www.cdc.gov/rsv/high-risk/older-adults.html
3.
Tseng
HF, Sy LS, Ackerson B, et al. Severe morbidity and short- and mid-
to long-term mortality in older adults hospitalized with
respiratory syncytial virus infection. J Infect Dis.
2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361.
Available
at: https://pubmed.ncbi.nlm.nih.gov/32591787/
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: June
07, 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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