REG - GSK PLC - Shingrix fully liquid accepted for US FDA review

GSKAnnouncement

10/01/2025 07:00

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RNS Number : 8268S  GSK PLC  10 January 2025

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  (#_edn1)

·   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  (#_edn2) 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  (#_edn3) 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  (#_edn4) By age 50, VZV is present
in most adults 5  (#_edn5) and may reactivate with advancing age.  6  (#_edn6)
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  (#_edn7) (, 8  (#_edn8) ) 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
(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.

 

Registered in England & Wales:

No. 3888792

 

Registered Office:

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WC1A 1DG

 

References

 1  (#_ednref1) . GSK data on file 2024.

 2  (#_ednref2) . Shingrix prescribing information. SHINGRIX (Zoster Vaccine
Recombinant, Adjuvanted), suspension for intramuscular injection
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Shingrix/pdf/SHINGRIX.PDF)
. Last accessed: January 2025.

 3  (#_ednref3) . CDC. About Shingles (Herpes Zoster). Available at
https://www.cdc.gov/shingles/about/index.html
(https://www.cdc.gov/shingles/about/index.html) . Last accessed: January 2025.

 4  (#_ednref4) . 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  (#_ednref5) . 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  (#_ednref6) . 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  (#_ednref7) . 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  (#_ednref8) . 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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