REG - GSK PLC - GSK’s Arexvy recommended by ACIP

GSKAnnouncement

22/06/2023 07:00

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RNS Number : 5251D  GSK PLC  22 June 2023

Issued: 22 June 2023, London UK

 

US Centers for Disease Control and Prevention's Advisory Committee on
Immunization Practices votes to recommend Arexvy for the prevention of RSV
disease in adults aged 60 and older with shared clinical decision making

 

·   Launch is planned in the US before the 2023 RSV season

·   Committee recommendations mean over 55 million older adults in the US
could have access to RSV vaccination for the first time(1)

·   RSV causes approximately 177,000 hospitalisations and 14,000 deaths in
adults aged 65 years and older in the US each year(2,3,4)

GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease
Control and Prevention's (CDC) Advisory Committee on Immunization Practices
(ACIP) voted in favour of recommending the use of Arexvy (respiratory
syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared
clinical decision making. Shared clinical decision making empowers patients in
consultation with their healthcare providers to determine whether RSV
vaccination is appropriate for them.

There are an estimated 55.8 million people aged 65 and older in the US(1) who
are at increased risk of RSV, a common, contagious virus that can lead to
serious respiratory illness.(2) RSV causes approximately 177,000
hospitalisations and an estimated 14,000 deaths in this age group in the US
each year.(2.3,4) For adults 60 and older, data suggest an increased risk for
severe RSV infection that can lead to hospitalisation.(5,6) Older adults,
including those with underlying medical conditions*, such as chronic heart
disease, chronic lung disease or diabetes, are at high risk of severe RSV
illness and account for the majority of RSV hospitalisations.(5)

( )

Tony Wood, Chief Scientific Officer, GSK, said: "GSK's successful
development of an RSV vaccine to help protect older adults from RSV lower
respiratory tract disease (LRTD) represents a major scientific advance,
resulting from years of collaboration across academia, industry, and research
centres. We are grateful to the ACIP and CDC for recognising the potential of
Arexvy and look forward to partnering with public health officials, healthcare
professionals and payers to make it available for eligible older adults in the
US before this year's RSV season begins."

 

In making its recommendation, the ACIP considered evidence from the
comprehensive data package supporting the vaccine, including in older adults
with underlying medical conditions. This includes results from the first
season of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase
III trial, published in the New England Journal of Medicine in February
2023.(7) During the ACIP meeting, GSK also presented data from the Northern
Hemisphere second season of the trial, which remains ongoing to explore the
effect of the vaccine over multiple seasons and the optimal timing for
potential revaccination. These data will be submitted to the US Food and Drug
Administration (FDA) for review.

The ACIP recommendations will be forwarded to the director of the CDC and the
US Department of Health and Human Services for review and approval. Once
approved, the final recommendations will be published in a future Morbidity
and Mortality Weekly Report (MMWR) to advise healthcare providers on
appropriate use of the vaccine.

* According to the CDC, adults aged 60 and older at even greater risk of
severe respiratory illness include those with chronic lung diseases, chronic
cardiovascular diseases, immune-compromise, hematologic disorders, neurologic
disorders, endocrine disorders, kidney and liver disorders and other factors
(8)

 

About Arexvy (respiratory syncytial virus vaccine, adjuvanted)

Respiratory syncytial virus vaccine, adjuvanted, contains recombinant
glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This
antigen is combined with GSK's proprietary AS01(E) adjuvant.(7)

 

The vaccine was approved by the US FDA on 3 May 2023 for the prevention of
LRTD caused by RSV in individuals 60 years of age and older.(9)

 

In clinical trials, the vaccine was generally well tolerated. The most
frequently observed solicited adverse events were injection site pain,
fatigue, myalgia, headache, and arthralgia. These were generally mild to
moderate and transient.(7)

 

In June 2023, the European Commission authorised the vaccine for active
immunisation for the prevention of LRTD caused by RSV in adults aged 60 years
and older.(10) Regulatory reviews in Japan and other counties are ongoing.

 

The vaccine is not approved anywhere else in the world. 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.

 

Please see the full US Prescribing
Information: https://www.fda.gov/media/167805/download

 

About RSV in older adults

RSV is a common contagious virus affecting the lungs and breathing
passages.(3) Older adults are at high risk for severe disease due in part to
age-related decline in immunity(3), and older adults with underlying
conditions are at even greater risk for severe disease.(5) RSV can exacerbate
conditions, including chronic obstructive pulmonary disease (COPD), asthma,
and chronic heart failure and can lead to severe outcomes, such as pneumonia,
hospitalisation, and death.(2) 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.(2,3,4) For adults 60 and older, data suggest an
increased risk for severe RSV infection that can lead to hospitalisation.(5,6)
Adults with underlying conditions are more likely to seek medical services and
have higher hospitalisation rates than adults without these conditions.(5)

 

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 the company's Annual Report on Form 20-F for 2022,
GSK's Q1 Results for 2023 and any impacts of the COVID-19 pandemic.

 

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References

1. United States Census Bureau. The older population: 2020. Accessed May 2023.
Available at:
https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-07.pdf

2. Centers for Disease Control and Prevention. RSV in Older Adults and Adults
with Chronic Medical Conditions. Accessed May 2023. Available at:
www.cdc.gov/rsv/high-risk/older-adults.html

3. National Foundation for Infectious Diseases. Respiratory Syncytial Virus.
Accessed May 2023. Available at: www.nfid.org/infectious-disease/rsv/

4. Falsey AR, et al. Respiratory syncytial virus infection in elderly and
high-risk adults. N Engl J Med 2005; 352:1749-1759.

5. Tseng HF, et al. Severe morbidity and short- and mid- to long-term
mortality in older adults hospitalized with respiratory syncytial virus
infection. J Infect Dis. 2020;222(8):1298-1310. doi:10.1093/infdis/jiaa361.
 

6. Belongia EA, et al. Clinical features, severity, and incidence of RSV
illness during 12 consecutive seasons in a community cohort of adults ≥60
years old. Open Forum Infect Dis. 2018;5(12):ofy316. doi:10.1093/ofid/ofy316.

7. Papi et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med 2023; 388:595-608.

8. CDC presentation. 21 June 2023. Available at:
www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-06-21-23/07-RSV-Adults-Britton-508.pdf

9. US FDA new release. Issued 3 May 2023. Available at:
www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine

10. European Medicines Agency. Recombinant respiratory syncytial virus
pre-fusion F protein, adjuvanted with AS01E. Available at:
www.ema.europa.eu/en/medicines/human/EPAR/arexvy#authorisation-details-section

 

 

 

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