REG - GSK PLC - EMA accepts Arexvy filing for adults 50-59 at risk

GSKAnnouncement

29/01/2024 07:15

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RNS Number : 1159B  GSK PLC  29 January 2024

Issued: 29 January 2024, London UK

 

GSK's RSV vaccine, Arexvy, accepted for regulatory review by the European
Medicines Agency for the prevention of RSV disease in adults aged 50-59 at
increased risk

 

·   Application supported by positive results of a Phase III study showing
immune response and acceptable tolerability profile in this population

·   Adults aged 50 and above with underlying medical conditions are at
increased risk for RSV disease 1  (#_edn1)

·   GSK is the first company to file for regulatory approval to extend RSV
vaccination to adults aged 50-59 at increased risk

 

 

 

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 adults
aged 50-59 who are at increased risk for RSV disease. If accepted, GSK's RSV
vaccine would be the first vaccine available to help protect this population.
Arexvy is currently approved in Europe in adults aged 60 and over for the
prevention of lower respiratory tract disease (LRTD) caused by RSV.

This regulatory submission follows 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/)
) from a phase III trial  NCT05590403  2  (#_edn2) evaluating the immune
response and safety of GSK's RSV vaccine in adults aged 50-59, including those
at increased risk for RSV-LRTD due to underlying medical conditions.

The burden of RSV disease in adults is likely to be underestimated due to lack
of awareness, lack of standardised testing, and under-detection in
surveillance studies. 3  (#_edn3) People with underlying medical conditions,
such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart
failure 4  (#_edn4) and diabetes 5  (#_edn5) are at increased risk for RSV
disease. RSV can exacerbate these conditions and lead to pneumonia,
hospitalisation, or death 6  (#_edn6) . The burden in adults aged 50-59 and at
increased risk for RSV disease is similar to that of 60 and above 7  (#_edn7)
.

GSK is the first company to file for regulatory approval to extend RSV
vaccination to help protect adults aged 50 to 59 at increased risk for RSV
disease due to underlying medical conditions. A European regulatory decision
is anticipated in Q3 2024.

 

About GSK's RSV vaccine

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 European Medicines Agency has approved GSK's RSV vaccine for the
prevention of lower respiratory tract disease (LRTD) caused by respiratory
syncytial virus (RSV) in individuals 60 years of age and older. 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, Japan, 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. Primary endpoints were met with non-inferior immune
responses observed in adults aged 50-59 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 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.(6) RSV can exacerbate conditions,
including COPD, asthma, and chronic heart failure and can lead to severe
outcomes, such as pneumonia, hospitalisation, and death.(6) Each year, RSV
causes approximately 270,000 hospitalisations and 20,000 in-hospital deaths in
adults 60 years of age and older in Europe.4

 

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) .

 

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) Malosh, 2017; Prasad, 2021, Begley, 2023. National Library of
Medicine, Respiratory Syncytial Virus hospitalisation in middle-aged and older
adults

 2  (#_ednref2) National Library of Medicine, [Study Details | A Study on the
Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus
Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of
Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older
Adults 60 Years of Age and Above | ClinicalTrials.gov]

 3  (#_ednref3) 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

 4  (#_ednref4) Falsey, AR et al. Respiratory syncytial virus infection in
elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59

 5  (#_ednref5) Richard Osei-Yeboah et al, Respiratory syncytial
virus-associated hospitalisation in adults with comorbidities in two European
countries, PROMISE investigators, preprint, August 2023

 6  (#_ednref6) Centers for Disease Control and Prevention (CDC), RSV in Older
Adults and Adults with Chronic Medical Conditions, 2023

 7  (#_ednref7) McClure et al. 2014. National Library of Medicine: Seasonal
incidence of medically attended respiratory syncytial virus infection in a
community cohort of adults >50 years old

 

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