REG - GSK PLC - EMA approval on Arexvy for 50-59 at risk

GSKAnnouncement

29/08/2024 07:00

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RNS Number : 0515C  GSK PLC  29 August 2024

Issued: 29 August 2024, London UK

 

European Commission approves expanded age indication for GSK's Arexvy, the
first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at
increased risk

 

·   An estimated 20 million adults aged 50-59 in 30 European countries*
have a medical condition that increases their risk for RSV disease(1-3)

·   Authorisation helps protect this population for the first time ahead of
this RSV season

·   This follows approval in US, with other countries anticipated,
including Japan later this year

 

 

GSK plc (LSE/NYSE: GSK) today announced that the European Commission has
authorised Arexvy (respiratory syncytial virus vaccine, recombinant
adjuvanted) for active immunisation for the prevention of lower respiratory
tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults
aged 50-59 who are at increased risk. Since June 2023, GSK's RSV vaccine has
been approved in Europe for adults aged 60 and over for the prevention of
RSV-LRTD(4).

 

Adults with underlying medical conditions, such as chronic obstructive
pulmonary disease (COPD), asthma, heart failure and diabetes are at increased
risk for severe consequences from an RSV infection compared to those without
these conditions(5,6). RSV can exacerbate these conditions and lead to
pneumonia, hospitalisation or death.(6)

 

It is estimated that there are about 65 million adults aged between 50 and 59
in the European Union/European Economic Area(1), with an estimated 20 million
of these people (one-third) having at least one underlying medical condition
that puts them at increased risk for RSV disease.(2,3)

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. RSV infection can have a significant impact on the
health of older adults and particularly those with certain existing medical
conditions, which can add pressure onto healthcare systems. As we enter the
RSV season, we are pleased to be the first to deliver a vaccine to help
protect more people in Europe from RSV-LRTD."

The regulatory application was supported by positive results from a phase III
trial 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.(7)

Prof. Dr. Tino F. Schwarz, Klinikum Würzburg Mitte, Würzburg, Germany
said: "There are a great number of patients in the age-group 50-59 years
living with certain underlying medical conditions with an increased risk for
severe RSV infection. These patients are likely to benefit from the extension
of the age indication of the RSV vaccine, helping to reduce the burden of
disease of RSV associated LRTDs. I hope that the NITAGs in Europe will rapidly
adapt the indication of RSV vaccination to include these patients".

 

In addition to the US and European approvals, GSK has also filed regulatory
submissions to extend the use of this vaccine to adults aged 50-59 at
increased risk, including 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 and immunocompromised
adults aged 18 and over are expected to read out in later in 2024.

 

About GSK's RSV vaccine

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

 

In June 2023, the European Commission 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 Arexvy EMA Reference Information, including a full list of adverse events
and the complete important safety information in the EU, will be available at
this link: www.ema.europa.eu/medicines/human//EPAR/arexvy
(http://www.ema.europa.eu/medicines/human/EPAR/arexvy)

 

The vaccine has also been approved for the prevention of RSV-LRTD in
individuals 60 years of age and older in 50 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 QS-21 STIMULON adjuvant
licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

 

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 certain underlying
medical conditions, 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)

 

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 Q2 Results for 2024.

 

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Notes:

*estimated from the % of individuals aged 50-59 in France, Italy and Spain
with at least one chronic condition(3) extrapolated to the EU/EEA population
of 50-59 years in 2024.(1) The European Commission has the authority to
approve medicines for the European Union member states, as well as in the
European Economic Area (EEA) countries Iceland, Norway and Liechtenstein.

 

References

 

1. United Nations. World Population Prospects 2024. Available at:
https://population.un.org/wpp/ (https://population.un.org/wpp/) - accessed in
August 2024

2. Zimmerman, RK et al., "Prevalence of high-risk indications for influenza
vaccine varies by age, race, and income" in Vaccine, 28(39), 6470-6477.3, 2010

3. de Fougerolles, TR. et al, "Public health and economic benefits of seasonal
influenza vaccination in risk groups in France, Italy, Spain and the UK: state
of play and perspectives" in BMC Public Health, 24(1), 1222, 2024

4. Arexvy | European Medicines Agency (EMA). (n.d.). European Medicines Agency
(EMA). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy.
(https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy.%20Accessed%20August%202024)
(https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy.%20Accessed%20August%202024)
Accessed August 2024
(https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy.%20Accessed%20August%202024)
- accessed in August 2024

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

6. Centers for Disease Control and Prevention (CDC), RSV in Adults. Available
at: https://www.cdc.gov/rsv/older-adults/index.html
(https://www.cdc.gov/rsv/older-adults/index.html) - accessed in August 2024

7. Ferguson, M. et al., "Noninferior Immunogenicity and Consistent Safety of
Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years
Compared to ≥60 Years of Age" in Clinical Infectious Diseases, ciae364,
2024. Advance online publication. doi.org/10.1093/cid/ciae364

 

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