Issued: 6 February 2024, London
UK
GSK's RSV vaccine, Arexvy, accepted under Priority Review
in US for the prevention of RSV disease in adults aged 50-59 at
increased risk
· Application supported by positive results of a phase III trial
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],[2],[3]
· GSK is the first
company to file for regulatory approval to extend RSV vaccination
to adults aged 50-59 at increased risk
· US FDA has set a Prescription Drug User Fee Act action date of
7th June
2024
GSK plc (LSE/NYSE: GSK)
today announced that the
US Food and Drug Administration (FDA) has
accepted under priority review an application to extend the
indication of GSK's adjuvanted respiratory syncytial virus (RSV)
vaccine to adults aged 50-59 who are at increased risk for RSV
disease. If approved, GSK's RSV vaccine
would be the first vaccine available to help protect this
population. Arexvy
is currently approved in the US in adults aged 60
and over for the prevention of lower respiratory tract disease
(LRTD) caused by RSV.
The application is supported by
positive results from a phase III trial [NCT05590403][4] 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.
GSK used a Priority Review Voucher to reduce the US FDA review
period of a supplemental Biologics License
Application (sBLA) by four months. The Prescription Drug User Fee
Act date, the FDA action date for their regulatory decision is
7
June 2024.
The burden of RSV disease in adults
is likely to be underestimated due to lack of awareness, a lack of
standardised testing, and under-detection in surveillance
studies.[5] People with underlying medical
conditions, such as chronic obstructive pulmonary disease (COPD),
asthma, chronic heart failure[6] and
diabetes,[7] are at increased risk for RSV
disease. RSV can exacerbate these conditions and lead to pneumonia,
hospitalisation, or death.[8]
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 FDA 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 RSV-LRTD in individuals 60 years of age and
older in Europe, 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. 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.8 RSV can exacerbate
conditions, including COPD, asthma, and chronic heart failure and
can lead to severe outcomes, such as pneumonia, hospitalisation,
and death.8 Each year,
approximately 177,000 adults 65 years and older are hospitalised in
the US due to RSV; an estimated 14,000 cases result in
death.6
Please see the full US Prescribing
Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
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 Q4 Results for
2023.
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References
[1] Malosh RE et
al. Respiratory syncytial
virus hospitalization in middle-aged and older adults.
J Clin
Virol. 2017; Nov:96:37-43. doi:
10.1016/j.jcv.2017.09.001
[2] Prasad N
et al. Respiratory Syncytial Virus-Associated Hospitalizations Among
Adults With Chronic Medical Conditions. Clin Infect
Dis. 2021 Jul 1;73(1):e158-e163.
doi: 10.1093/cid/ciaa730.
[3] Begley KM
et al. Prevalence and Clinical Outcomes of Respiratory Syncytial
Virus vs Influenza in Adults Hospitalized With Acute Respiratory
Illness From a Prospective Multicenter Study. Clin Infect Dis. 2023 Jun
8;76(11):1980-1988. doi: 10.1093/cid/ciad031.
[4] ClinicalTrials.gov, 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 2023.
NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403
[5] 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
[6] Falsey, AR
et al. Respiratory syncytial virus infection in elderly and high-risk
adults, in New Engl J Med
2005; 352:1749-59
[7] Richard
Osei-Yeboah et al,
Respiratory syncytial virus-associated hospitalisation in adults
with comorbidities in two European countries, PROMISE
investigators, preprint, August 2023
[8] Centers for
Disease Control and Prevention (CDC), RSV in Older Adults and
Adults with Chronic Medical Conditions, 2023