REG - GSK PLC - Japan approves first RSV vaccine for adults 50-59

GSKAnnouncement

22/11/2024 07:00

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RNS Number : 2595N  GSK PLC  22 November 2024

Issued: 22 November 2024, London UK

 

Arexvy approval expanded to adults aged 50-59 at increased risk of severe RSV
disease in Japan

 

·   First RSV vaccine approved in Japan to help protect 50-59 year olds at
increased risk due to certain underlying health conditions

·   RSV infections can exacerbate these underlying health conditions and
lead to severe outcomes, such as pneumonia, hospitalisation and death(1)

·   35 countries, including the US, have expanded approval for GSK's RSV
vaccine in this at increased risk population

 

GSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health,
Labour and Welfare (MHLW) has approved a regulatory application to extend the
indication of Arexvy (respiratory syncytial virus vaccine, recombinant
adjuvanted) for the prevention of RSV disease to include adults aged 50-59 at
increased risk. Since September 2023, GSK's RSV vaccine has been approved in
Japan for adults aged 60 and over for the prevention of RSV disease.(2)

Tony Wood, Chief Scientific Officer at GSK, said: "This approval reflects our
ambition to protect people at increased risk from the severe consequences of
RSV infection. Adults aged 50-59 with certain underlying medical conditions
can face debilitating consequences from RSV, so we are pleased to offer those
in Japan a vaccine for the first time."

RSV is a common contagious virus affecting the lungs and breathing passages
and it impacts an estimated 64 million people of all ages globally every
year.(3) Adults can be at increased risk for RSV disease due to certain
underlying medical conditions, immune compromised status, or advanced age.(1)
RSV infection can exacerbate conditions, including COPD, asthma, and chronic
heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.(1)

This regulatory expansion was supported by results from a global phase III
trial (including 4 clinical sites in Japan) that showed non-inferior
immunogenicity in adults aged 50-59 at increased risk of RSV lower respiratory
tract disease compared to those aged 60 and older.(4) Safety and
reactogenicity in the 50-59 at increased risk population were consistent with
results from the initial phase III programme in adults aged 60 and older. (4)

To date, GSK's RSV vaccine has been approved for adults aged 50-59 at
increased risk in 35 countries, including the US, with regulatory decisions
for other geographies undergoing review.

About GSK's RSV vaccine

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

 

In September 2023, the MHLW approved GSK's RSV vaccine for the prevention of
RSV (respiratory syncytial virus) disease for adults aged 60 years and above
in Japan. 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 Arexvy Product Information, including a full list of adverse events and
the complete important safety information in Japan, will be available from the
Japan Pharmaceuticals and Medical Devices Agency.
(https://www.info.pmda.go.jp/psearch/html/menu_tenpu_base.html)

 

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 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.     Centers for Disease Control and Prevention (CDC), RSV in Adults.
Available at: https://www.cdc.gov/rsv/older-adults/index.html
(https://www.cdc.gov/rsv/older-adults/index.html) - accessed in November 2024

2.     Package insert in Japanese of Arexvy Intramuscular Injection,
Revised Oct 2024 2(nd) edition, Available at:
https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/340278_631341NE1021_1_03
(https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/340278_631341NE1021_1_03)
- accessed in November 2024

3.     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: November 2024

4.     Ferguson, M. et al., "Noninferior Immunogenicity and Consistent
Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults
50-59 Years Compared to ≥60 Years of Age" in Clinical Infectious Diseases,
2024; 79(4): 1074 . doi.org/10.1093/cid/ciae364

 

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