Issued: 10 January 2025, London
UK
GSK's Shingrix
new prefilled
syringe presentation accepted for review by US
FDA
· If approved, the new presentation will offer a convenient
administration option to healthcare professionals
· Over 90 million doses of GSK's shingles vaccine have been
distributed in the US since 2017[1]
· An FDA decision on the application is expected by 20 June
2025
GSK plc (LSE/NYSE: GSK) today
announced that the US Food and Drug Administration (FDA) has
accepted for review the regulatory application of a prefilled
syringe presentation of Shingrix (GSK's Recombinant Zoster
Vaccine or RZV) for the prevention of shingles (herpes
zoster).
The new prefilled syringe removes the
need to reconstitute separate vials prior to administration,
offering a convenient option for pharmacists, physicians and other
healthcare professionals who administer vaccinations. The current
presentation of the vaccine consists of a lyophilised (powder)
antigen and a liquid adjuvant, which healthcare professionals
combine prior to administering. The new presentation has the same
composition as the reconstituted vaccine and the submission is
based on data demonstrating comparability between the two.
1
Today's announcement marks an
important regulatory milestone for GSK's shingles vaccine, which
has been approved in the US for the prevention of shingles in
adults aged 50 years and older since 2017; and in adults 18 years
and older, who are or will be at increased risk of shingles due to
immunodeficiency or immunosuppression caused by known disease or
therapy, since 2021. [2] It reflects
GSK's continued innovation on its commercialised portfolio to meet
the needs of the healthcare community.
About shingles
Shingles is a painful, blistering
rash that can last for weeks. Approximately 99% of US adults over
50 years old have the virus that causes shingles inside their body,
although not everyone will develop shingles. [3] An estimated one million people develop shingles
annually in the US. 3
Shingles is caused by the
reactivation of the varicella-zoster virus (VZV), the same virus
that causes chickenpox. [4] By age 50, VZV
is present in most adults[5] and may
reactivate with advancing age. [6] As people
age, the strength of the immune system response to infection wanes,
increasing the risk of developing shingles. 6
About Shingrix
(Recombinant Zoster Vaccine or RZV)
Shingrix (GSK's Recombinant
Zoster Vaccine or RZV) is a non-live, recombinant subunit vaccine
indicated for the prevention of shingles in adults 50 and over. It
combines an antigen, glycoprotein E, with an adjuvant system,
AS01B, and may help overcome the natural age-related decline in
responses to immunisation that contributes to the challenge of
protecting adults aged 50 and over from shingles. [7],[8] RZV is not
indicated to prevent primary varicella infection (chickenpox). In
several countries, RZV is also approved for adults aged 18 years or
over at increased risk for shingles. The use of RZV should be in
accordance with official recommendations and local product
label.
The following information is based on
the US Prescribing Information (PI) for Shingrix. Please refer to the US PI at
this link:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF
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.
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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 GSK's
Annual Report on Form 20-F for 2023, and GSK's Q3 Results for
2024.
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References
[1]. GSK data on file
2024.
[4]. Harpaz R, et al.
Advisory Committee on Immunization Practices (ACIP), Centers for
Disease Control and Prevention (CDC). Prevention of herpes zoster:
recommendations of the Advisory Committee on Immunization Practices
(ACIP). MMWR Recomm Rep. 2008;57(RR-5):1-30.
[5]. Johnson, R.W., et
al. Herpes zoster epidemiology, management, and disease and
economic burden in Europe: a multidisciplinary perspective.
Therapeutic advances in vaccines. 2015;3(4):109-20.
[6]. Mueller, N.H., et
al. Varicella zoster virus infection: clinical features, molecular
pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[7]. Cunningham, AL,
et al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70
Years of Age or Older. New England Journal of Medicine.
2016;375(11):1019-32.
[8]. The GSK
proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant
licensed from Antigenics LLC, a wholly owned subsidiary of Agenus
Inc. (NASDAQ: AGEN), MPL and liposomes.
