REG - GSK PLC - FDA Ad Com votes to support GSK RSV OA vaccine

GSKAnnouncement

02/03/2023 07:01

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RNS Number : 5977R  GSK PLC  01 March 2023

Issued: 1 March 2023, London UK

 

US FDA Advisory Committee votes to support effectiveness and safety of GSK's
respiratory syncytial virus older adult vaccine candidate

 

·   Committee votes unanimously that the data support the effectiveness of
the vaccine, and 10-2 that the data support the safety of the vaccine

·   FDA decision on US approval expected by 3 May 2023, with the potential
for the vaccine to be the first approved for older adults

·   Evidence reviewed by the Committee was supported by pivotal data
recently published in the New England Journal of Medicine

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) Vaccines and Related Biological Products Advisory
Committee (VRBPAC) voted that the available data support the safety and
effectiveness of GSK's respiratory syncytial virus (RSV) older adult vaccine
candidate for the prevention of lower respiratory tract disease (LRTD) caused
by RSV in adults aged 60 years and older. The Committee voted unanimously 12-0
on effectiveness and 10-2 on safety.

Phil Dormitzer, Global Head of Vaccines R&D, GSK said: "Today's vote
brings us an important step closer to delivering one of the world's first
vaccines for RSV, a respiratory virus that causes potentially debilitating
disease and imposes a major burden on healthcare systems. Thousands of older
adults in the US are impacted by RSV and those with underlying health
conditions, like respiratory and heart diseases and diabetes, are at increased
risk of severe complications. We're delighted that the Advisory Committee
recognised the strength of our vaccine's data and its potential to make a
positive public health impact with a unanimous vote on the effectiveness of
the vaccine."

 

The Committee based its vote on the robust data package supporting the vaccine
candidate. This includes results from the pivotal AReSVi-006
(Adult Respiratory Syncytial Virus) phase III trial, recently published in
the New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa2209604) . In addition, GSK
presented positive data on concomitant administration with seasonal
quadrivalent influenza vaccination previously shared at IDWeek 2022.

 

The role of the VRBPAC is to provide non-binding recommendations for
consideration by the FDA, with the final decision on approval made by the FDA.
In November 2022, the FDA accepted the Biologics License Application (BLA)
for GSK's RSV older adult vaccine candidate under Priority Review and assigned
a Prescription Drug User Fee Act action date of 3 May 2023.

 

GSK's RSV older adult vaccine candidate is also under regulatory review by the
European Medicines Agency, Japan's Ministry of Health, Labour and Welfare, and
several other regulators, with decisions expected in 2023. Additional
regulatory submissions are anticipated to continue throughout this year.

 

About GSK's RSV older adult vaccine candidate

GSK's RSV older adult vaccine candidate contains a recombinant subunit
prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's
proprietary AS01(E) adjuvant. Across multiple trials, the vaccine candidate
was generally well tolerated with an acceptable safety profile. The most
frequently observed solicited adverse events were injection site pain,
fatigue, myalgia, and headache. These were typically mild to moderate and
transient. The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus
Inc.

 

There are currently no RSV vaccines approved anywhere in the world.

 

About RSV in adults

RSV is a common contagious virus affecting the lungs and breathing passages.
It is one of the major remaining infectious diseases for which there is
currently no vaccine or specific treatment available for adults. 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 other conditions, including chronic
obstructive pulmonary disease, asthma and chronic heart failure and can lead
to severe complications, such as pneumonia, hospitalisation, and death. Each
year RSV causes over 470,000 hospitalisations and 33,000 deaths in adults in
high-income countries.(1) 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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q4 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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References

1.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. Influenza Other
Respir Viruses 2022 November 11 (Epub ahead of print). [PMID: 36369772].
Accessed February 2022. Available at: Respiratory syncytial virus disease
burden in adults aged 60 years and older in high
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) ‐
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) income countries: A
systematic literature review and meta
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) ‐
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031) analysis - Savic -
Influenza and Other Respiratory Viruses - Wiley Online Library
(https://onlinelibrary.wiley.com/doi/10.1111/irv.13031)

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