REG - GSK PLC - GSK submits Arexvy for adults 18+ with EMA

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RNS Number : 6370M  GSK PLC  13 June 2025

Issued: 13 June 2025, London UK

 

GSK's RSV vaccine, Arexvy, accepted for regulatory review by the European
Medicines Agency to expand use in adults 18 years and older

 

·   Regulatory decision anticipated H1 2026

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency
(EMA) has accepted the company's regulatory application to expand the use of
its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to
include adults from 18 years of age. Arexvy was the first RSV vaccine
approved in the European Economic Area for the prevention of lower respiratory
tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those
aged 50-59 years who are at increased risk for RSV disease.

 

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

 

A European regulatory decision on this submission is anticipated in H1 2026.
GSK is continuing to seek expanded indications for its RSV vaccine in other
geographies including the US and Japan.

 

About GSK's RSV vaccine

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV
glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This
antigen is combined with GSK's proprietary AS01(E) adjuvant.

 

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 vaccine has been approved for the prevention of RSV-LRTD in individuals 60
years of age and older in more than 60 countries. In addition, it is approved
for use in individuals aged 50-59 who are at increased risk due to certain
underlying medical conditions in more than 50 markets, including the US, Japan
and Europe.

 

Please refer to the updated Product Information (PI) for important dosage,
administration, and safety information in Europe at this
link: http://www.ema.europa.eu/medicines/human//EPAR/arexvy
(http://www.ema.europa.eu/medicines/human/EPAR/arexvy)

 

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 RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages,
and impacts an estimated 64 million people of all ages globally every year.(1)
Adults can be at increased risk for RSV disease due to certain comorbidities,
immune compromised status, or advanced age.(4) RSV can exacerbate conditions,
including COPD, asthma, and chronic heart failure and can lead to severe
outcomes, such as pneumonia, hospitalisation, and death.(4)

 

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.

Registered in England & Wales:

No. 3888792

 

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WC1A 1DG

 

Notes:

*The European Medicines Agency reviews medicines for European Union member
states, as well as in the European Economic Area (EEA) countries Iceland,
Norway and Liechtenstein.

 

References:

1.     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)
. Accessed June 2025

2.     Osei-Yeboah R, et al. Estimation of the Number of Respiratory
Syncytial Virus-Associated Hospitalizations in Adults in the European Union. J
Infect Dis 2023 May 29;228(11):1539-1548. doi: 10.1093/infdis/jiad189
(https://academic.oup.com/jid/article/228/11/1539/7184171)

3.     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. (https://pubmed.ncbi.nlm.nih.gov/33249288/)

4.     Falsey, AR et al. Respiratory syncytial virus infection in elderly
and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi:
10.1056/NEJMoa043951 (https://doi.org/10.1056/nejmoa043951)

 

 

 

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