REG - GSK PLC - Shingrix 18+ at risk China filing review accepted

GSKAnnouncement

06/02/2024 07:15

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RNS Number : 1542C  GSK PLC  06 February 2024

Issued: 6 February 2024, London UK

 

GSK's regulatory application for Shingrix for the prevention of shingles in
at-risk adults aged 18 and over accepted for review by China National Medical
Products Administration

 

·   Shingrix already approved in China for adults aged 50 years and over

·   Application could expand populations eligible to benefit from
protection against shingles to include adults with an increased risk of the
disease

·   Approximately six million cases of shingles in China each year, with
the incidence over three times higher for adults at increased risk compared to
the general population

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the Center for Drug Evaluation
(CDE) of the China National Medical Products Administration (NMPA) has
accepted for review the regulatory application of Shingrix (Recombinant Zoster
Vaccine or RZV) for the prevention of shingles (herpes zoster) in adults aged
18 years and over at increased risk.

 

Recombinant Zoster Vaccine (RZV) is a non-live, recombinant subunit adjuvanted
vaccine given intramuscularly in two doses and was initially approved in 2019
by the NMPA to prevent shingles in adults aged 50 years and over.(1-3)

 

Globally, shingles will affect up to 1 in 3 people in their lifetime.(4-7) A
variety of factors can increase the risk of developing shingles, including
advancing age and immunodeficiency or immunosuppression,(8) as well as other
chronic conditions such as COPD, diabetes, and asthma.(9) It is estimated that
there are approximately 6 million cases of shingles in China each year,(10)
with the incidence in people who are at increased risk, including people who
are immunocompromised either due to disease or therapeutic treatment, being
over three times higher than the general population.(11)

 

The NMPA application is informed by six clinical trials in patients aged 18
years and over who had undergone recent blood-forming cells (stem cell)
transplantation, kidney transplant, or have blood cancer, solid tumour, or
HIV.(12-17)

 

About shingles

Shingles is caused by the reactivation of the varicella-zoster virus (VZV),
the same virus that causes chickenpox.(4) A variety of factors can increase
the risk of developing shingles, including advancing age and immunodeficiency
or immunosuppression,(8) as well as other chronic conditions such as COPD,
diabetes, and asthma.(9)

 

Shingles typically presents as a rash, with painful blisters across the chest,
abdomen, or face.(18) The pain is often described as aching, burning, stabbing
or shock-like.(4) Following the rash, a person can also experience
post‑herpetic neuralgia (PHN), a long-lasting nerve pain that can last weeks
or months and can occasionally persist for several years.(4) PHN is the most
common complication of shingles, occurring in 5-30% of all shingles cases from
findings in various studies.(19)

 

About Shingrix

Shingrix (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.(1,2) RZV is not indicated to prevent primary varicella
infection (chickenpox). In some 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.

 

Please refer to the Product Information (PI) for important dosage,
administration and safety information in China available at this link:
https://www.gsk-china.com/media/6506/4-
(https://www.gsk-china.com/media/6506/4-%E8%AF%B4%E6%98%8E%E4%B9%A6-pdf-145m-ppc-0025427-v3-clean.pdf)
说明书
(https://www.gsk-china.com/media/6506/4-%E8%AF%B4%E6%98%8E%E4%B9%A6-pdf-145m-ppc-0025427-v3-clean.pdf)
-pdf-145m-ppc-0025427-v3-clean.pdf
(https://www.gsk-china.com/media/6506/4-%E8%AF%B4%E6%98%8E%E4%B9%A6-pdf-145m-ppc-0025427-v3-clean.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 the company's Annual Report on Form 20-F for 2022,
and Q4 Results for 2023.

 

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References

 

1. Cunningham, A.L., 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):1019-1032.

2. 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.

3. GSK. GSK announces approval of Shingrix in China for prevention of shingles
in adults aged 50 and over. Available at:
https://www.gsk.com/en-gb/media/press-releases/gsk-announces-approval-of-shingrix-in-china-for-prevention-of-shingles-in-adults-aged-50-and-over/
(https://www.gsk.com/en-gb/media/press-releases/gsk-announces-approval-of-shingrix-in-china-for-prevention-of-shingles-in-adults-aged-50-and-over/)
. Last accessed: January 2024.

4. Harpaz, R., et al. Prevention of herpes zoster: recommendations of the
Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep
2008;57(Rr-5):1-30.

5. Shingles in Australia. Australian Institute of Health and Welfare
[Available from:
https://www.aihw.gov.au/getmedia/759199ff-f5c8-421d-a572-aaa984a02b49/aihw-phe-236_shingles.pdf.aspx
Last Accessed: November 2023

6. Lee, C., et al. Lifetime risk of herpes zoster in the population of
Beijing, China. Public health in practice (Oxford, England). 2023;5:100356.

7. Curran, D., et al. Meta-Regression of Herpes Zoster Incidence Worldwide.
Infectious diseases and therapy. 2022;11(1):389-403.

8. Chen S-Y, et al. Incidence of herpes zoster in patients with altered immune
function. Infection. 2014; 42: 325-334.

9. Marra F, et al. Risk Factors for Herpes Zoster Infection: A Meta-Analysis.
Open Forum Infect Dis 2020;7(1):ofaa005.

10. Zhang, Z., et al. The incidence of herpes zoster in China: A meta-analysis
and evidence quality assessment. Human vaccines & immunotherapeutics.
2023;19(2):2228169.

11. Zhenwei L, et al. Study on the risk of recurrence of herpes zoster in
adults based on a retrospective cohort design. Zhejiang University of
Traditional Chinese Medicine Conference.

12. Bastidas, A., et al. Effect of Recombinant Zoster Vaccine on Incidence of
Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized
Clinical Trial. JAMA. 2019;322(2):123-33.

13. Vink, P., et al. Immunogenicity and safety of the adjuvanted recombinant
zoster vaccine in patients with solid tumors, vaccinated before or during
chemotherapy: A randomized trial. Cancer. 2019;125(8):1301-12.

14. Dagnew, A.F., et al. Immunogenicity and safety of the adjuvanted
recombinant zoster vaccine in adults with haematological malignancies: a phase
3, randomised, clinical trial and post-hoc efficacy analysis. The Lancet
Infectious Diseases. 2019;19(9):988-1000.

15. Stadtmauer, E.A., et al. A phase 1/2 study of an adjuvanted
varicella-zoster virus subunit vaccine in autologous hematopoietic cell
transplant recipients. Blood. 2014;124 (19):2921-2929.

16. Berkowitz, E.M., et al. Safety and immunogenicity of an adjuvanted herpes
zoster subunit candidate vaccine in HIV-infected adults: a phase 1/2a
randomized, placebo-controlled study. The Journal of infectious diseases.
2015;211(8):1279-1287.

17. GSK. Abstract on file.

18. Mueller, N.H., et al. Varicella zoster virus infection: clinical features,
molecular pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-697.

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

 

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