Issued: 29 July 2024, London
UK
Arexvy, GSK's Respiratory Syncytial
Virus (RSV) vaccine, receives positive European Medicines Agency
CHMP opinion for adults aged 50-59 at increased risk for RSV
disease
· If
approved, this will be the first vaccine in the EU for adults aged
50-59 who are at increased risk of respiratory syncytial virus
disease
· Decision on EU marketing authorisation for this population
expected by September 2024
GSK plc (LSE/NYSE: GSK) today
announced that the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP) has recommended expanding
the approval of GSK's respiratory syncytial virus (RSV) vaccine for
the prevention of lower respiratory tract disease (LRTD) caused by
RSV from adults aged 60 and above to include adults aged 50-59
years at increased risk for RSV disease.
Today's positive opinion
is the first time that an indication for adults
aged 50-59 has been recommended by CHMP for a RSV vaccine, one of
the final steps prior to the extension of the marketing
authorisation by the European Commission.
The European Commission's final decision is
expected by September 2024. Since June
2023, Arexvy
(respiratory syncytial virus vaccine, recombinant
adjuvanted) has been approved in Europe for
adults aged 60 and over for the prevention of
RSV-LRTD.
Adults with underlying medical
conditions, such as chronic obstructive pulmonary disease (COPD),
asthma, heart failure[1] and
diabetes[2] are at
increased risk for severe consequences from an RSV infection
compared to those without these conditions. RSV can exacerbate
these conditions and lead to pneumonia, hospitalisation or
death.1
Each year, RSV causes approximately
270,000 hospitalisations and 20,000 in-hospital deaths in adults 60
years of age and older in Europe.[3]
The burden of RSV disease in at increased risk
adults aged 50-59 is similar to that of the overall population aged
60 and above.[4]
The positive opinion is supported by
results from a phase III trial [NCT05590403][5] 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.
GSK's RSV vaccine was approved by
the US FDA for adults aged 50-59 at increased risk on 7 June 2024.
GSK has also filed regulatory submissions to expand the use of its
RSV vaccine to adults aged 50-59 at increased risk 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 due to certain underlying
medical conditions and in immunocompromised adults aged 18 and over
are expected to read out in H2 2024.
About GSK's RSV Vaccine
Respiratory Syncytial Virus Vaccine,
recombinant, adjuvanted, contains recombinant RSV glycoprotein F
stabilised in the prefusion conformation (RSVPreF3). This antigen
is combined with GSK's proprietary
AS01E adjuvant.
The vaccine was approved in Europe
for adults aged 60 and over for the prevention of RSV-LRTD in June
2023. 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 vaccine has also been approved
for the prevention of RSV-LRTD in individuals 60 years of age and
older in over 45 countries, including the 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 STIMULON QS-21 adjuvant licensed from Antigenics
Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a
trademark of SaponiQx Inc., a subsidiary of Agenus.
About RSV in older adults
RSV is a common contagious virus
affecting the lungs and breathing passages. Adults can be at
increased risk for RSV disease due to comorbidities, immune
compromised status, or advanced age. RSV can exacerbate conditions,
including COPD, asthma, and chronic heart failure and can lead to
severe outcomes, such as pneumonia, hospitalisation, and
death.1 Each year RSV causes
approximatively 470,000 hospitalisations and 33,000 deaths in
adults aged 60 and older in high-income
countries.3
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 Q1 Results for 2024.
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References