REG - GSK PLC - Japan accepts Arexvy filing for at risk adults

GSKAnnouncement

12/12/2023 07:00

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RNS Number : 3875W  GSK PLC  12 December 2023

Issued: 12 December 2023, London UK

 

Japan's Ministry of Health, Labour and Welfare accepts Arexvy regulatory
application to prevent RSV disease in adults aged 50-59 at increased risk

 

·   Submission supported by positive results of a Phase III study showing
immune response and safety in adults aged 50-59

·   Adults aged 50 and above with certain underlying medical conditions are
at increased risk for RSV disease

·   GSK is the first company to seek regulatory approval to extend RSV
vaccination to this population

 

 

 

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

This regulatory submission follows Japan's approval of GSK's vaccine for the
prevention of RSV disease in adults from the age of 60 years, and the recent
announcement of the positive results
(https://www.gsk.com/en-gb/media/press-releases/new-data-for-arexvy-show-potential-to-help-protect-adults-aged-50-to-59/
(https://www.gsk.com/en-gb/media/press-releases/new-data-for-arexvy-show-potential-to-help-protect-adults-aged-50-to-59/)
) of a phase III trial [NCT05590403
https://clinicaltrials.gov/study/NCT05590403
(https://clinicaltrials.gov/study/NCT05590403) ] evaluating the immune
response and safety of GSK's RSV vaccine in adults aged 50-59, including those
at increased risk for RSV lower respiratory tract disease (LRTD) due to
certain underlying medical conditions.

The burden of RSV disease in adults is likely to be underestimated due to lack
of awareness and standardised testing, as well as under-detection within
surveillance studies 1  (#_edn1) , but people with underlying medical
conditions - such as chronic obstructive pulmonary disease (COPD), asthma,
chronic heart failure 2  (#_edn2) and diabetes 3  (#_edn3) - are at increased
risk for RSV disease. RSV can exacerbate these conditions and lead to
pneumonia, hospitalisation, or death. 4  (#_edn4) An international systematic
review of the prevalence of respiratory viruses in patients with acute
exacerbations of COPD, for example, showed that RSV was detected 1 in 10
cases. 5  (#_edn5)

 

GSK is the first company to seek regulatory approval to extend RSV vaccination
to help protect adults aged 50 to 59 at increased risk for RSV disease.
Further announcements on regulatory progress in the US and EU are expected in
early 2024.

 

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. 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 also been approved for the prevention of lower respiratory
tract disease (LRTD) caused by RSV in individuals 60 years of age and older in
the US, Europe, UK, Canada and several other countries. Regulatory reviews in
multiple countries are ongoing. The proposed trade name remains subject to
regulatory approval in other markets.

 

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 NCT05590403 trial

NCT05590403 is a phase III, placebo-controlled, observer-blind, randomized,
multi-country immunogenicity trial to evaluate the non-inferiority of the
immune response and evaluate safety in participants aged 50 to 59 at increased
risk of RSV-LRTD compared to older adults aged 60 years and above after a
single dose of GSK's RSV vaccine.

The study assessed the immune response in participants aged 50 to 59 with
pre-defined stable chronic diseases leading to an increased risk of RSV
disease (n=570). Immune responses in a broader group of participants aged
50-59 years without these pre-defined chronic diseases (n=570) were also
evaluated compared to adults aged 60 and older. The trial's primary endpoints
were RSV-A and RSV-B neutralisation titres of both groups of 50 to 59 year
olds at one month after the vaccine administration compared to adults aged 60
and older. There were also safety and immunogenicity secondary and tertiary
endpoints.

 

Results from this trial will be presented at upcoming medical conferences and
submitted for peer-reviewed publication. The data have been presented at the
US Centers for Disease Control and Prevention's (CDC) Advisory Committee on
Immunization Practices (ACIP) meeting on 25 October 2023 and are being
submitted to other regulators to support potential label expansions.

 

About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages.
Adults can be at increased risk for RSV disease due to 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). Each year, RSV
causes approximatively 470,000 hospitalisations and 33,000 in-hospital deaths
in adults 60 years of age and older in industrialised countries, including
approximately 63,000 hospitalisations and 4,500 deaths in Japan(1). Adults
with underlying conditions are more likely to seek medical advice and have
higher hospitalisation rates than adults without these conditions 6  (#_edn6)
.

 

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

 

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 Q3 Results for 2023.

 

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References

 1  (#_ednref1) Savic M, Penders Y, Shi T, Branche A, Pirçon J-Y. Respiratory
syncytial virus disease burden in adults aged 60 years and older in
high-income countries: a systematic literature review and meta-analysis,
Influenza Other Respir Viruses 2022 2023; 17:e13031

 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) Richard Osei-Yeboah et al, Respiratory syncytial
virus-associated hospitalisation in adults with comorbidities in two European
countries, PROMISE investigators, preprint, August 2023

 4  (#_ednref4) Centers for Disease Control and Prevention (CDC), RSV in Older
Adults and Adults with Chronic Medical Conditions, 2023

 5  (#_ednref5) Zwaans WA et al., The relevance of respiratory viral
infections in the exacerbations of chronic obstructive pulmonary disease-A
systematic review, in J Clin Virol 2014;61:181-188

 6  (#_ednref6) Branche AR et al. Incidence of Respiratory Syncytial Virus
Infection Among Hospitalized Adults, 2017-2020, Clin Infect Dis
2022;74:1004-1011

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