REG - GSK PLC - CHMP positive opinion on Arexvy for 50-59 at risk

GSKAnnouncement

29/07/2024 07:00

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RNS Number : 1086Y  GSK PLC  29 July 2024

Issued: 29 July 2024, London UK

 

Arexvy, GSK's Respiratory Syncytial Virus (RSV) vaccine, receives positive
European Medicines Agency CHMP opinion for adults aged 50-59 at increased risk
for RSV disease

 

·   If approved, this will be the first vaccine in the EU for adults aged
50-59 who are at increased risk of respiratory syncytial virus disease

·   Decision on EU marketing authorisation for this population expected by
September 2024

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has recommended
expanding the approval of GSK's respiratory syncytial virus (RSV) vaccine for
the prevention of lower respiratory tract disease (LRTD) caused by RSV from
adults aged 60 and above to include adults aged 50-59 years at increased risk
for RSV disease.

 

Today's positive opinion is the first time that an indication for adults aged
50-59 has been recommended by CHMP for a RSV vaccine, one of the final steps
prior to the extension of the marketing authorisation by the European
Commission. The European Commission's final decision is expected by September
2024. Since June 2023, Arexvy (respiratory syncytial virus vaccine,
recombinant adjuvanted) has been approved in Europe for adults aged 60 and
over for the prevention of RSV-LRTD.

 

Adults with underlying medical conditions, such as chronic obstructive
pulmonary disease (COPD), asthma, heart failure 1  (#_edn1) and diabetes 2 
(#_edn2) ( )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.(1)

 

Each year, RSV causes approximately 270,000 hospitalisations and 20,000
in-hospital deaths in adults 60 years of age and older in Europe. 3  (#_edn3)
The burden of RSV disease in at increased risk adults aged 50-59 is similar to
that of the overall population aged 60 and above. 4  (#_edn4)

 

The positive opinion is supported by 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.

 

GSK's RSV vaccine was approved by the US FDA for adults aged 50-59 at
increased risk on 7 June 2024. GSK has also filed regulatory submissions to
expand the use of its RSV vaccine to adults aged 50-59 at increased risk in
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 due to certain underlying medical conditions and in
immunocompromised adults aged 18 and over are expected to read out in H2
2024.

 

About GSK's RSV Vaccine

Respiratory Syncytial Virus Vaccine, recombinant, adjuvanted, contains
recombinant RSV glycoprotein F stabilised in the prefusion conformation
(RSVPreF3). This antigen is combined with GSK's proprietary AS01(E) adjuvant.

 

The vaccine was approved in Europe for adults aged 60 and over for the
prevention of RSV-LRTD in June 2023. 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 45 countries, including the 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 RSV in older 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. RSV can exacerbate conditions, including
COPD, asthma, and chronic heart failure and can lead to severe outcomes, such
as pneumonia, hospitalisation, and death.(1) Each year RSV causes
approximatively 470,000 hospitalisations and 33,000 deaths in adults aged 60
and older in high-income countries.(3)

 

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 GSK's Annual Report on Form 20-F for 2023, and GSK's Q1 Results
for 2024.

 

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References

 

 

 1  (#_ednref1) Centers for Disease Control and Prevention (CDC), RSV in
Adults, 2024 - available: https://www.cdc.gov/rsv/older-adults/index.html

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

 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, in
Influenza Other Respir Viruses 2022 2023; 17:e13031

 4  (#_ednref4) McClure DL et al. Seasonal incidence of medically attended
respiratory syncytial virus infection in a community cohort of adults >50
years old. PLoS One 2014; 9(7): e102586.

 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. https://www.clinicaltrials.gov/study/NCT05590403
(https://www.clinicaltrials.gov/study/NCT05590403)

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