REG - GSK PLC - EMA accept review Shingrix syringe presentation

GSKAnnouncement

27/01/2025 07:15

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RNS Number : 7634U  GSK PLC  27 January 2025

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  (#_edn1) (, 2  (#_edn2) , 3  (#_edn3) , 4  (#_edn4) )

·   Over 25 million people in Europe have received GSK's shingles vaccine
since 2018 5  (#_edn5)

 

 

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  (#_edn6)

 

About shingles

Shingles typically presents as a rash, with painful blisters across the chest,
abdomen or face. 7  (#_edn7) Following the rash, up to 30% of people
experience PHN, 8  (#_edn8)  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  (#_edn9)

 

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  (#_edn10) 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  (#_edn11) (, 12  (#_edn12) ) 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
(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

 1  (#_ednref1) . 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.

 2  (#_ednref2) . Australian Institute of Health and Welfare. Shingles in
Australia. Available
at: https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx
(https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx)
Last Accessed: November 2024.

 3  (#_ednref3) . Lee C, et al. Lifetime risk of herpes zoster in the
population of Beijing, China. Public Health Pract (Oxf). 2023;5:100356.

 4  (#_ednref4) . Curran D, et al. Meta-Regression of Herpes Zoster Incidence
Worldwide. Infect Dis Ther. 2022;11(1):389-403.

 5  (#_ednref5) . GSK data on file 2024.

 6  (#_ednref6) . Shingrix EU product information.
https://www.ema.europa.eu/en/documents/product-information/shingrix-epar-product-information_en.pdf
(https://www.ema.europa.eu/en/documents/product-information/shingrix-epar-product-information_en.pdf)
Last accessed: November 2024.

 7  (#_ednref7) . Mueller, N.H., et al. Varicella zoster virus infection:
clinical features, molecular pathogenesis of disease, and latency. Neurologic
clinics. 2008;26(3):675-97.

 8  (#_ednref8) . Kawai, K., et al. Systematic review of incidence and
complications of herpes zoster: towards a global perspective. BMJ open.
2014;4(6).

 9  (#_ednref9) . Rampakakis E, Stutz M, Kawai K, Tsai TF, Cheong HJ, Dhitavat
J, et al. Association between work time loss and quality of life in patients
with Herpes Zoster: a pooled analysis of the MASTER studies. Health and
Quality of Life Outcomes. 2017;15(1).

 10  (#_ednref10) . 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.

 11  (#_ednref11) . 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.

 12  (#_ednref12) . 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.

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