REG - GSK PLC - US FDA approves GSK’s RSV vaccine for older adults

GSKAnnouncement

03/05/2023 18:00

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RNS Number : 3350Y  GSK PLC  03 May 2023

Issued: 3 May 2023, London UK

 

US FDA approves GSK's Arexvy, the world's first respiratory syncytial virus
(RSV) vaccine for older adults

 

·   Ground-breaking approval enables adults aged 60 years and older to be
protected from RSV disease for the first time

·   The approval is based on data from the positive pivotal AReSVi-006
phase III trial that showed exceptional efficacy in older adults, including
those with underlying medical conditions, and in those with severe RSV disease

·   US launch is planned before the 2023/24 RSV season

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine,
adjuvanted) for the prevention of lower respiratory tract disease (LRTD)
caused by respiratory syncytial virus (RSV) in individuals 60 years of age and
older. This is the first RSV vaccine for older adults to be approved anywhere
in the world.

 

Tony Wood, Chief Scientific Officer, GSK, said: "Today marks a turning point
in our effort to reduce the significant burden of RSV. Arexvy is the first
approved RSV vaccine for older adults, expanding GSK's industry-leading
vaccine portfolio, which protects millions of people from infectious diseases
each year. Our focus now is to ensure eligible older adults in the US can
access the vaccine as quickly as possible and to progress regulatory review in
other countries."

 

RSV is a common, contagious virus that can lead to potentially serious
respiratory illness. It causes approximately 177,000 hospitalisations and an
estimated 14,000 deaths in the US in adults aged 65 years and older each
year.(1,2,3) Older adults, including those with underlying medical conditions
such as diabetes and chronic heart and lung disease, are at increased risk of
severe RSV illness and drive the majority of RSV hospitalisations.(4)

 

John Kennedy, MD, President, American Medical Group Association (AMGA) added:
"For decades, AMGA and the healthcare community at large have been active in
finding ways to increase adult immunisations. As a result, we are pleased that
we can now add a respiratory syncytial virus vaccine to providers' options for
patient care. With this vaccine, Americans over the age of 60, and
particularly those with underlying health conditions like COPD, asthma, or
congestive heart failure, will have a vaccine to help protect against
potentially serious outcomes from RSV."

 

The US FDA approval is based on GSK's landmark positive pivotal AReSVi-006
(Adult Respiratory Syncytial Virus) phase III trial data. In the trial, the
vaccine showed statistically significant and clinically meaningful overall
efficacy of 82.6% (96.95% CI, 57.9-94.1, 7 of 12,466 vs 40 of 12,494) against
RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In
addition, efficacy was 94.6% (95% CI, 65.9-99.9, 1 of 4,937 vs 18 of 4,861) in
older adults with at least one underlying medical condition of interest, such
as certain cardiorespiratory and endocrine-metabolic conditions. Efficacy
against severe RSV-LRTD, defined as an RSV-associated LRTD episode preventing
normal, everyday activities, was 94.1% (95% CI, 62.4-99.9, 1 of 12,466 vs 17
of 12,494).

 

The vaccine was generally well tolerated with an acceptable safety profile.
The most frequently observed solicited adverse events were injection site
pain, fatigue, myalgia, headache, and arthralgia. These were generally mild to
moderate and transient.

 

In June 2023, the Advisory Committee on Immunization Practices (ACIP) will
make recommendations on the appropriate use of the vaccine in the US. The
vaccine will be available for older adults before the 2023/24 RSV season,
which typically starts ahead of the winter months.

 

In April 2023, the European Medicines Agency's Committee for Medicinal
Products for Human Use (CHMP) issued a positive opinion recommending the
vaccine for the prevention of LRTD caused by RSV in adults aged 60 years and
older. A final European regulatory decision is anticipated in the coming
months, while regulatory reviews are ongoing in Japan and several other
countries.

 

About Arexvy (respiratory syncytial virus vaccine, adjuvanted)

Respiratory syncytial virus vaccine, adjuvanted, contains a recombinant
subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's
proprietary AS01(E) adjuvant.

 

In the US, Arexvy is indicated for the prevention of RSV-LRTD in individuals
60 years of age and older. GSK's RSV older adult vaccine is not currently
approved anywhere outside the US. The proposed trade name remains subject to
regulatory approval outside the US.

 

A clinical trial that aims to expand the population who may benefit from RSV
vaccination into adults aged 50-59, including participants with underlying
comorbidities, is fully recruited. Results are expected in 2023, together with
additional results from the AReSVi-006 phase III efficacy trial and the
AReSVi-004 immunogenicity trial. These trials continue to evaluate an annual
revaccination schedule and protection/immunogenicity over multiple seasons
following one dose of the RSV vaccine. Results from two additional influenza
vaccine co-administration trials are also expected before the June 2023
Advisory Committee on Immunization Practices (ACIP) meeting.

 

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://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF)

 

About RSV in older adults

RSV is a common contagious virus affecting the lungs and breathing passages.
Older adults are at high risk for severe disease due in part to age-related
decline in immunity, and older adults with underlying conditions are at even
greater risk for severe disease. 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. 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.(3) 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.

 

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/company
(https://www.gsk.com/en-gb/company/) .

 

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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. Centers for Disease Control and Prevention. RSV Transmission. Accessed
March 2023. Available at: https://www.cdc.gov/rsv/about/transmission.html
(https://www.cdc.gov/rsv/about/transmission.html%20)

2. National Foundation for Infectious Diseases. Respiratory Syncytial Virus in
Older Adults: A Hidden Annual Epidemic. 2016. Accessed March 2023. Available
at: https://www.nfid.org/wp-content/uploads/2019/08/rsv-report.pdf
(https://www.nfid.org/wp-content/uploads/2019/08/rsv-report.pdf)

3. Falsey AR, et al. N Engl J Med 2005; 352:1749-1759 DOI:
10.1056/NEJMoa043951. Accessed March 2023.

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

5. Tseng HF, Sy LS, Ackerson B, 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, King JP, Kieke BA, 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.

 

 

 

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