REG - GSK PLC - FDA approves Arexvy for adults 50-59 at risk

GSKAnnouncement

10/06/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240610:nRSJ6407Ra&default-theme=true

RNS Number : 6407R  GSK PLC  10 June 2024

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  (#_edn1)

·   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 
(#_edn2) Adults with underlying medical conditions, such as chronic
obstructive pulmonary disease (COPD), asthma, heart failure and diabetes 3 
(#_edn3) 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  (#_edn4)

 

(*)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  (#_edn5) 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 AS01(E) 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 older(6) and 42,000 in adults aged 50-64 years old in the US(2).

 

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  (#_ednref1) 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 - 27(th)
Annual Conference on Vaccinology Research - NFID 2024; May 8-10, 2024

 2  (#_ednref2) 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  (#_ednref3) Branche AR et al., « Incidence of Respiratory Syncytial
Virus Infection Among Hospitalized Adults, 2017-2020" in Clinical Infectious
Diseases, 2022:74:1004-1011

 4  (#_ednref4) Centers for Disease Control and Prevention (CDC), RSV in Older
Adults and Adults with Chronic Medical Conditions, 2024

 5  (#_ednref5) 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

( )

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCQKOBQCBKKAAK