REG - GSK PLC - FDA accepts Arexvy filing for adults 50-59 at risk

GSKAnnouncement

06/02/2024 07:15

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RNS Number : 0963C  GSK PLC  06 February 2024

Issued: 6 February 2024, London UK

 

GSK's RSV vaccine, Arexvy, accepted under Priority Review in US for the
prevention of RSV disease in adults aged 50-59 at increased risk

 

·   Application supported by positive results of a phase III trial showing
immune response and acceptable tolerability profile in this population

·   Adults aged 50 and above with underlying medical conditions are at
increased risk for RSV disease( 1  (#_edn1) )(, 2  (#_edn2) , 3  (#_edn3) )

·    GSK is the first company to file for regulatory approval to extend RSV
vaccination to adults aged 50-59 at increased risk

·   US FDA has set a Prescription Drug User Fee Act action date of 7(th)
June 2024

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted under priority review an application to
extend the indication of GSK's adjuvanted respiratory syncytial virus (RSV)
vaccine to adults aged 50-59 who are at increased risk for RSV disease. If
approved, GSK's RSV vaccine would be the first vaccine available to help
protect this population. Arexvy is currently approved in the US in adults aged
60 and over for the prevention of lower respiratory tract disease (LRTD)
caused by RSV.

The application is supported by positive results from a phase III trial
 NCT05590403  4  (#_edn4) 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 underlying medical conditions. GSK used a Priority Review
Voucher to reduce the US FDA review period of a supplemental Biologics License
Application (sBLA) by four months. The Prescription Drug User Fee Act date,
the FDA action date for their regulatory decision is 7 June 2024.

The burden of RSV disease in adults is likely to be underestimated due to lack
of awareness, a lack of standardised testing, and under-detection in
surveillance studies. 5  (#_edn5) People with underlying medical conditions,
such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart
failure 6  (#_edn6) and diabetes, 7  (#_edn7) are at increased risk for RSV
disease. RSV can exacerbate these conditions and lead to pneumonia,
hospitalisation, or death. 8  (#_edn8)

 

About GSK's RSV Vaccine

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.

 

The FDA has approved GSK's RSV vaccine for the prevention of lower respiratory
tract disease (LRTD) caused by respiratory syncytial virus (RSV) in
individuals 60 years of age and older. 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 Europe, Japan, UK, Canada and several
other countries. 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 the NCT05590403 trial

NCT05590403 is a phase III, placebo-controlled, observer-blind, randomized,
multi-country immunogenicity trial to evaluate the non-inferiority of the
immune response and evaluate safety in participants aged 50 to 59 at increased
risk of RSV-LRTD compared to older adults aged 60 years and above after a
single dose of GSK's RSV vaccine.

 

The study assessed the immune response in participants aged 50 to 59 with
pre-defined stable chronic diseases leading to an increased risk of RSV
disease (n=570). Immune responses in a broader group of participants aged
50-59 years without these pre-defined chronic diseases (n=570) were also
evaluated compared to adults aged 60 and older. The trial's primary endpoints
were RSV-A and RSV-B neutralisation titres of both groups of 50 to 59 year
olds at one month after the vaccine administration compared to adults aged 60
and older. There were also safety and immunogenicity secondary and tertiary
endpoints.

 

Results from this trial will be presented at upcoming medical conferences and
submitted for peer-reviewed publication. The data are being submitted to other
regulators to support potential label expansions.

 

About RSV in 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.(8) RSV can exacerbate conditions,
including COPD, asthma, and chronic heart failure and can lead to severe
outcomes, such as pneumonia, hospitalisation, and death.(8) 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.(6)

 

Please see the full US Prescribing Information:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Arexvy/pdf/AREXVY.PDF

 

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,
and Q4 Results for 2023.

 

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References

 1  (#_ednref1) Malosh RE et al. Respiratory syncytial virus hospitalization
in middle-aged and older adults. J Clin Virol. 2017; Nov:96:37-43. doi:
10.1016/j.jcv.2017.09.001

 2  (#_ednref2) Prasad N et al. Respiratory Syncytial Virus-Associated
Hospitalizations Among Adults With Chronic Medical Conditions. Clin Infect
Dis. 2021 Jul 1;73(1):e158-e163. doi: 10.1093/cid/ciaa730.

 3  (#_ednref3) Begley KM et al. Prevalence and Clinical Outcomes of
Respiratory Syncytial Virus vs Influenza in Adults Hospitalized With Acute
Respiratory Illness From a Prospective Multicenter Study. Clin Infect Dis.
2023 Jun 8;76(11):1980-1988. doi: 10.1093/cid/ciad031.

 4  (#_ednref4) ClinicalTrials.gov, A Study on the Immune Response and Safety
of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years
of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus
Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and
Above 2023. NCT05590403. https://www.clinicaltrials.gov/study/NCT05590403
(https://www.clinicaltrials.gov/study/NCT05590403)

 5  (#_ednref5) 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 2023; 17:e13031

 6  (#_ednref6) Falsey, AR et al. Respiratory syncytial virus infection in
elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59

 7  (#_ednref7) Richard Osei-Yeboah et al, Respiratory syncytial
virus-associated hospitalisation in adults with comorbidities in two European
countries, PROMISE investigators, preprint, August 2023

 8  (#_ednref8) Centers for Disease Control and Prevention (CDC), RSV in Older
Adults and Adults with Chronic Medical Conditions, 2023

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