GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk

• Submission supported by positive results of a Phase III study showing immune response and tolerability in adults aged 50-59
• Adults aged 50 and above with underlying medical conditions are at increased risk for RSV disease^1,2,3
• GSK is the first company to seek regulatory approval to extend RSV vaccination to this population

MISSISSAUGA, ON - GSK (GlaxoSmithKline Inc.) has submitted a Supplementary New Drug Submission (SNDS) to Health Canada to expand the use of Arexvy, GSK's respiratory syncytial virus (RSV) vaccine (recombinant, AS01_E adjuvanted), to include adults aged 50-59 at increased risk for RSV disease. If approved, GSK's RSV vaccine would be the first vaccine available in Canada to help protect this population.

This submission follows the August 2023 approval of Arexvy in Canada for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.⁴ The SNDS filing is based on the positive results from a phase III trial [NCT05590403] evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59 at increased risk for RSV lower respiratory tract disease due to underlying medical conditions.

People with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure⁵ and diabetes,⁶ are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalization, or death.⁷

GSK is the first company to file for regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease due to underlying medical conditions. Regulatory submissions are also under review by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Ministry of Health, Labour and Welfare (MHLW). The safety and effectiveness of Arexvy in adults aged 50-59 at increased risk for RSV disease are still under investigation and authorization has not yet been granted. A Canadian regulatory decision is anticipated in the second half of 2024.

About Arexvy

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.

Arexvy is currently approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.

The vaccine has also been approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older in the US, Europe, Japan, UK 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. The burden of RSV disease in adults is likely to be underestimated due to lack of awareness and standardized testing, as well as under-detection within surveillance studies.⁹ Adults can be at increased risk for RSV disease due to comorbidities, immune compromised status, or advanced age.⁷ RSV can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.⁷ Each year, RSV causes approximatively 470,000 hospitalizations and 33,000 in-hospital deaths in adults 60 years of age and older in industrialised countries.⁹ Adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates than adults without these conditions.¹⁰

The Product Monograph, posted at www.ca.gsk.com, should be consulted for complete administration and safety information.

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.ca.

References

[1] Malosh RE et 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] 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] 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] Arexvy Canadian Product Monograph. Available at https://ca.gsk.com/en-ca/products/arexvy/

[5] Falsey, AR et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59

[6] Richard Osei-Yeboah et al, Respiratory syncytial virus-associated hospitalisation in adults with comorbidities in two European countries, PROMISE investigators, preprint, August 2023

[7] Centers for Disease Control and Prevention (CDC), RSV in Older Adults and Adults with Chronic Medical Conditions, 2023

[8] Zwaans WA et al., The relevance of respiratory viral infections in the exacerbations of chronic obstructive pulmonary disease-A systematic review, in J Clin Virol 2014;61:181-188

[9] 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

[10] Branche AR et al. Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017-2020, Clin Infect Dis 2022;74:1004-1011

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