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]
· 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/)
from a phase III trial [NCT05590403][2] 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] People with underlying medical
conditions, such as chronic obstructive pulmonary disease (COPD),
asthma, chronic heart failure[4] and
diabetes[5] are at increased risk for RSV
disease. RSV can exacerbate these conditions and lead to pneumonia,
hospitalisation, or death[6]. The burden in adults aged 50-59 and at increased risk for RSV
disease is similar to that of 60 and above[7].
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 AS01E 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.
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.
GSK
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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] Malosh, 2017;
Prasad, 2021, Begley, 2023. National
Library of Medicine, Respiratory Syncytial Virus hospitalisation in
middle-aged and older adults
[2] 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] 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] Falsey, AR
et al. Respiratory syncytial virus infection in elderly and high-risk
adults, in New Engl J Med
2005; 352:1749-59
[5] Richard
Osei-Yeboah et al,
Respiratory syncytial virus-associated hospitalisation in adults
with comorbidities in two European countries, PROMISE
investigators, preprint, August 2023
[6] Centers for
Disease Control and Prevention (CDC), RSV in Older Adults and Adults with Chronic
Medical Conditions, 2023
[7] 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