Issued: 27 January 2025, London
UK
GSK's Shingrix
new prefilled
syringe presentation accepted for review by European Medicines
Agency
· If approved, the new presentation will offer a convenient
administration option to healthcare professionals
· Globally, up to 1 in 3 adults will develop shingles in their
lifetime[1],[2],[3],[4]
· Over 25 million people in Europe have received GSK's shingles
vaccine since 2018[5]
GSK plc (LSE/NYSE: GSK) today
announced that the European Medicines Agency (EMA) 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 physicians, pharmacists 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.5
This European regulatory review
follows the file acceptance by the US FDA on 8 January 2025 for the
new prefilled syringe presentation, continuing GSK's commitment to
providing solutions to increasing adult immunisation. GSK is also
investigating submission of this presentation to other markets.
GSK's shingles vaccine has been approved in the European Union for
the prevention of herpes zoster (HZ) and post-herpetic neuralgia
(PHN) in adults aged 50 years and older since 2018; and in adults
18 years and older at increased risk of HZ, since 2020.[6]
About shingles
Shingles typically presents as a
rash, with painful blisters across the chest, abdomen or
face.[7] Following the rash, up to 30% of
people experience PHN,[8] a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several
years.1 Shingles is also
associated with significant healthcare and human cost, with 57% of
people with shingles reported missing work for an average of 9.1
days.[9]
Shingles is caused by the
reactivation of the varicella-zoster virus (VZV), the same virus
that causes chickenpox.1 By age 50, VZV is
present in most adults[10] and in some
may reactivate with advancing age.7 As people age, the
strength of the immune system response to infection wanes,
increasing the risk of developing shingles.7
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.[11],[12] 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.
Please refer to the Product
Information (PI) for important dosage, administration, and safety
information in Europe available at this
link: https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix
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
