REG - GSK PLC - GSK RSV OA vaccine gains positive EMA CHMP opinion

GSKAnnouncement

27/04/2023 07:00

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RNS Number : 6159X  GSK PLC  27 April 2023

Issued: 27 April 2023, London UK

 

GSK's respiratory syncytial virus older adult vaccine candidate gains positive
European Medicines Agency CHMP opinion

 

·   Positive opinion advances GSK's goal to provide the first vaccine to
help protect older adults from respiratory syncytial virus disease

·   Opinion is supported by data showing the vaccine candidate's
exceptional efficacy in older adults, including those with underlying medical
conditions

·   Decision on EU marketing authorisation expected by July 2023

 

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency's
Committee for Medicinal Products for Human Use (CHMP) has adopted a positive
opinion by consensus recommending approval of GSK's respiratory syncytial
virus (RSV) vaccine candidate for the prevention of lower respiratory tract
disease (LRTD) caused by RSV in adults aged 60 years and older. This is the
first time an RSV vaccine candidate for adults has gained a positive opinion,
one of the final steps in the marketing authorisation procedure prior to
approval by the European Commission.

 

There are no RSV vaccines or specific treatments currently available for older
adults. RSV causes over 270,000 hospitalisations and approximately 20,000
in-hospital deaths in adults aged 60 years and older each year in Europe.(1)
If approved, GSK's candidate has the potential to be the first vaccine
available to help protect older adults from RSV disease.

 

GSK's marketing authorisation application has been reviewed under accelerated
assessment. This applies to products determined by the CHMP to be of major
interest for public health and therapeutic innovation. The European
Commission's final decision is expected by July 2023.

 

The positive opinion is supported by data from the pivotal AReSVi-006
(https://www.gsk.com/en-gb/media/press-releases/gsk-s-older-adult-respiratory-syncytial-virus-rsv-vaccine-candidate/)
(Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial. In the
trial, the vaccine candidate showed 82.6% (96.95% CI, 57.9-94.1, 7 of 12,466
vs. 40 of 12,494) overall vaccine efficacy against RSV-LRTD in adults aged 60
years and older, meeting the primary endpoint. 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
endocrino-metabolic conditions. 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.

 

GSK's RSV older adult vaccine candidate is also under regulatory review by the
US Food and Drug Administration, Japan's Ministry of Health, Labour and
Welfare, and several other regulatory agencies, with decisions expected in
2023. Additional regulatory submissions will continue throughout this year.

 

About GSK's RSV older adult vaccine candidate

GSK's RSV older adult vaccine candidate contains a recombinant subunit RSV
prefusion F glycoprotein antigen (RSVPreF3) combined with the Company'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, headache, and arthralgia. 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.

 

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 candidate. Results from two additional
influenza vaccine co-administration trials are also expected in H1 2023.

 

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 aged
60 and above 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/)

 

 GSK enquiries
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 Investor Relations:  Nick Stone         +44 (0) 7717 618834   (London)
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                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 4855       (Philadelphia)

 

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.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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