Issued: 7 June 2024, London
UK
US
FDA approves expanded age indication for GSK's Arexvy, the first respiratory
syncytial virus (RSV) vaccine for adults aged 50-59 at increased
risk
· Over 13 million US adults aged 50-59 years have a medical
condition that increases their risk of severe RSV
outcomes[1]
· Clinical development programme
continues to evaluate safety and immunogenicity in adults 18+ with
data read-outs expected H2 2024
GSK plc (LSE/NYSE: GSK) today
announced that the US Food and Drug Administration (FDA) has
approved Arexvy
(Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted)
for the prevention of RSV lower respiratory tract
disease (LRTD) in adults 50 through 59 years of age who are at
increased risk. In the US, the vaccine is currently approved for
use in adults aged 60 and older and recommended by CDC/ACIP
using shared clinical
decision-making.
A systematic review of studies in the
US showed that RSV is estimated to cause 42,000
hospitalisations* each year in adults aged 50-64 years
old.[2] Adults with
underlying medical conditions, such as chronic obstructive
pulmonary disease (COPD), asthma, heart failure and
diabetes[3] are at increased risk for severe
consequences from an RSV infection compared to those without these
conditions. RSV can exacerbate these conditions and lead to
pneumonia, hospitalisation or death.[4]
*adjusted for
under-detection
Tony Wood, Chief Scientific Officer, GSK,
said: "Today's approval reflects the importance of broadening the
benefits of RSV immunisation to adults aged 50-59 who are at
increased risk. For those with underlying medical conditions, RSV
can have serious consequences, so we are proud to be the first to
help protect them from RSV-LRTD."
The regulatory application was
supported by positive results from a phase III trial
[NCT05590403][5] 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 certain underlying
medical conditions.
Professor Ann R. Falsey, University of Rochester School of
Medicine, said: "I am thrilled that
GSK's RSV vaccine is now approved for adults aged 50-59 at
increased risk of RSV-LRTD. When it comes to the risks associated
with RSV, age is just a number, an important number, but not the
only factor to consider. Many adults in this age group have
underlying health conditions that place them at increased risk for
serious illness with RSV infection compared with those without
these conditions. Now there is a vaccine approved that can help
protect them."
GSK has also filed regulatory
submissions to extend the use of its RSV vaccine to adults aged
50-59 at increased risk in Europe, Japan and other geographies with
regulatory decisions undergoing review. Trials evaluating the
immunogenicity and safety of the vaccine in adults aged 18-49 at
increased risk and immunocompromised adults aged 18 and over are
expected to read out in H2 2024.
About GSK's RSV vaccine
Respiratory Syncytial Virus Vaccine,
Adjuvanted, contains recombinant RSV glycoprotein F stabilised in
the prefusion conformation (RSVPreF3). This antigen is combined
with GSK's proprietary AS01E adjuvant.
In May 2023, the FDA 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 over 40 countries, including Europe, Japan and US.
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, randomised, multi-country
immunogenicity trial to evaluate the non-inferiority of the immune
response and evaluate safety in participants aged 50 to 59,
including those at increased risk for 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 for 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 at one month after the vaccine
administration compared to adults aged 60 and older. There were
also safety and immunogenicity secondary and tertiary endpoints.
Safety and reactogenicity data were consistent with results from
the initial AReSVi-006 data read out. The most common local adverse
event was pain. The most common systematic adverse events were
myalgia, fatigue and headache, which were largely transient and
mild to moderate in intensity.
Results from this trial have been
presented at the ACIP meeting of October 2023 and at ReSVinet in
February 2024, and have been 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.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 is
estimated to cause approximately 177,000
hospitalisations in adults 65 years and older6
and 42,000 in adults aged 50-64 years old
in the US2.
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
enquiries
|
|
|
|
Media:
|
Tim Foley
|
+44 (0) 20 8047 5502
|
(London)
|
|
Simon Moore
|
+44 (0) 20 8047 5502
|
(London)
|
|
Kathleen Quinn
|
+1 202 603 5003
|
(Washington DC)
|
|
Alison Hunt
|
+1 540 742 3391
|
(Washington DC)
|
|
|
|
|
Investor Relations:
|
Nick Stone
|
+44 (0) 7717 618834
|
(London)
|
|
James Dodwell
|
+44 (0) 20 8047 2406
|
(London)
|
|
Mick Readey
|
+44 (0) 7990 339653
|
(London)
|
|
Josh Williams
|
+44 (0) 7385 415719
|
(London)
|
|
Camilla Campbell
|
+44 (0) 7803 050238
|
(London)
|
|
Steph Mountifield
|
+44 (0) 7796 707505
|
(London)
|
|
Jeff McLaughlin
|
+1 215 751 7002
|
(Philadelphia)
|
|
Frannie DeFranco
|
+1 215 751 4855
|
(Philadelphia)
|
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 Q1 Results for 2024.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References
[1] Horn et al,
"Disparities in Risk Factors for Severe Respiratory Syncytial Virus
Disease among Adults in the United States", Abstract presented at
National Foundation for Infectious Diseases - 27th
Annual Conference on Vaccinology Research - NFID 2024; May 8-10,
2024
[2] McLaughlin JM et
al, "Rates of Medically Attended RSV Among US Adults: A Systematic
Review and Meta-analysis" in Open
Forum Infectious Diseases, Volume 9, Issue 7, July
2022
[3] Branche AR
et al., « Incidence
of Respiratory Syncytial Virus Infection Among Hospitalized Adults,
2017-2020" in Clinical Infectious
Diseases, 2022:74:1004-1011
[4] Centers for
Disease Control and Prevention (CDC), RSV in Older Adults and
Adults with Chronic Medical Conditions, 2024
[5] 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.
6 Falsey, AR et
al. Respiratory syncytial virus
infection in elderly and high-risk adults, in New Engl J Med 2005;
352:1749-59