REG - GSK PLC - Arexvy filed in Japan for 18-49 at increased risk

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RNS Number : 6662N  GSK PLC  20 June 2025

Issued: 20th June 2025, London UK

 

Japan's Ministry of Health, Labour and Welfare accepts regulatory application
to expand use of GSK's RSV vaccine, Arexvy, in adults aged 18-49 at increased
risk of severe RSV disease.

 

·   If approved, GSK's RSV vaccine would be the first available in Japan to
help protect this group

·   Submission supported by positive Phase IIIb data showing immune
response and safety in this population

 

GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health,
Labour and Welfare (MHLW) has accepted the company's regulatory application to
expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV)
vaccine to include adults aged 18-49 at increased risk of severe RSV disease.
Arexvy was the first vaccine approved in Japan for adults aged 60 years and
older for the prevention of RSV disease, and for those aged 50 years and older
at increased risk for severe RSV disease.

RSV is a common, contagious virus affecting the lungs and breathing passages
impacting an estimated 64 million people of all ages globally every year. 1 
(#_edn1) RSV can exacerbate certain medical conditions, and lead to severe
illness resulting in hospitalisation and even death 2  (#_edn2) (, 3  (#_edn3)
, 4  (#_edn4) ).

This regulatory submission is supported by positive results from phase IIIb
trial NCT06389487 5  (#_edn5) which showed a non-inferior immune response in
adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying
medical conditions, to that observed in adults aged 60 and above. The safety
and reactogenicity data were consistent with results from the phase III
programme that supported the initial approval of the vaccine in Japan.

 

GSK is the first company to seek regulatory approval for the vaccine to help
protect adults aged 18-49 at increased risk of severe RSV disease in Japan.
Regulatory submissions to expand the indications for the RSV vaccine continue
in other geographies including the US and Europe.

 

About Arexvy

Respiratory syncytial virus vaccine, adjuvanted, contains recombinant
glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This
antigen is combined with GSK's proprietary AS01(E) adjuvant.

 

The MHLW has approved GSK's RSV vaccine for the prevention of RSV (respiratory
syncytial virus) disease for adults aged 60 years and above and adults aged 50
and older who are considered at increased risk of severe RSV disease. The use
of this vaccine should be in accordance with official recommendations. As with
any vaccine, a protective immune response may not be elicited in all
vaccinees.

 

The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant
licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.
STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.

 

About the NCT06389487 trial

NCT06389487 is a phase IIIb open-label study to evaluate the non-inferiority
of the immune response and to evaluate the safety of GSK's RSV vaccine in
adults aged 18-49 at increased risk for RSV disease (n=426) compared to adults
aged 60 and older (n=429). An additional cohort of 603 participants aged 18-49
were followed up for adverse events separate to safety follow up of the
initial cohort. 1,458 participants were enrolled across 52 locations in 6
countries, including 4 sites in Japan.

 

The trial's co-primary endpoints were RSV-A and RSV-B neutralisation titers
expressed as mean geometric titer ratio (relative to older adults over adults
at increased risk) and sero-response rate in RSV-A and RSV-B neutralising
titers one month post vaccine administration. There were also safety and
immunogenicity secondary endpoints.

 

About RSV in adults

 

RSV is a common contagious virus affecting the lungs and breathing passages.
RSV impacts an estimated 64 million people of all ages globally every year.(1)
Adults can be at increased risk for RSV disease due to comorbidities, immune
compromised status, or advanced age.2 RSV can exacerbate conditions, including
COPD, asthma, and chronic heart failure and can lead to severe outcomes, such
as pneumonia, hospitalisation, and death.2

 

Please refer to the updated Product Information (PI) for important dosage,
administration, and safety information in Japan at this
link: https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html
(https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html)

 

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 in
the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q1 Results for 2025.

 

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References

 1  (#_ednref1) National Institute of Allergy and Infectious Diseases,
Respiratory Syncytial Virus (RSV). Available at:
https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv
(https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv)
- last accessed: June 2025

 2  (#_ednref2) Falsey, AR et al. Respiratory syncytial virus infection in
elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59

 3  (#_ednref3) Osei-Yeboah, R et al. Respiratory Syncytial Virus-Associated
Hospitalization in Adults with Comorbidities in 2 European Countries: A
Modeling Study. J Infect Dis; 2024; 229 (suppl 1): S70-S77

 4  (#_ednref4) Atamna A, Babich T, Froimovici D, Yahav D, Sorek N, Ben-Zvi H,
Leibovici L, Bishara J, Avni T. Morbidity and mortality of respiratory
syncytial virus infection in hospitalized adults: Comparison with seasonal
influenza. Int J Infect Dis. 2021 Feb;103:489-493. doi:
10.1016/j.ijid.2020.11.185.

 5  (#_ednref5)  Clinicaltrials.gov, "A Study on the Immune Response and
Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18
to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease,
Compared to Older Adults 60 Years of Age and Above" - available at:
https://clinicaltrials.gov/study/NCT06389487
(https://clinicaltrials.gov/study/NCT06389487)

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