GSK Canada submits respiratory syncytial virus (RSV) vaccine candidate for regulatory review

• Vaccine candidate has the potential to be the first available to help protect adults aged 60 years and older from lower respiratory tract disease caused by respiratory syncytial virus
  
  
• Application includes important pivotal phase III data evaluating the efficacy and safety of our vaccine candidate against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above
  
  
• Canadian regulatory submission follows regulatory submissions in the US, Europe and Japan

MISSISSAUGA, ON, Nov. 25, 2022 /CNW/ - GSK has filed a New Drug Submission (NDS) to Health Canada for its respiratory syncytial virus (RSV) older adult vaccine candidate. If approved, GSK's RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

Canada's regulatory filing follows regulatory submission acceptances by the US Food and Drug Administration (FDA), the European Medicines Agency and Japan's Ministry of Health, Labour and Welfare. There are currently no RSV vaccines for older adults approved anywhere in the world.

RSV outbreaks typically occur in late fall through early spring, peaking during the winter months.ⁱ Currently, according to the Public Health Agency of Canada, RSV activity remains above expected levels for this time of year.ⁱⁱ

Marni Freeman, Country Medical Director, GSK Canada, said: "RSV has evaded scientists for over 60 years. Today, innovations in structural biology and immunology have brought us closer to finding new ways to help protect people and provide customized solutions. As a global leader in vaccines, with more than 20 commercialized vaccines and 21 vaccine candidates in our pipeline, we are excited for the potential that GSK's RSV vaccine candidate has to help reduce the significant burden of RSV in older adults."

Older adults are at a greater risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death.^iii,iv

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.  The regulatory submission includes important data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial showing vaccine efficacy and safety against RSV lower respiratory tract disease (LRTD) in adults aged 60 years and older.

About the AReSVi-006 trial
The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomized, placebo-controlled, observer-blind, multi-country trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 older adult investigational vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries, including Canada.

The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.  

About respiratory syncytial virus (RSV)
RSV (respiratory syncytial virus) is a virus that infects 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. In adults, RSV infection is typically mild, but may lead to severe outcomes. Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including COPD, asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalization, and death. Each year, RSV causes over 420,000 hospitalizations and 29,000 deaths in adults aged 60 years and older in industrialized countries. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates than adults without these conditions.

About GSK
GSK is a science-led global healthcare company. For further information please visit www.ca.gsk.com/en-ca

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	^i RSV. Lung Association. Retrieved from https://www.lung.ca/lung-health/lung-disease/respiratory-syncytial-virus-rsv. Accessed November 2022.
	^ii Respiratory Virus Report, Week 46 - ending November 19, 2022. Government of Canada. https://www.canada.ca/en/public-health/services/surveillance/respiratory-virus-detections-canada/2022-2023/week-46-ending-november-19-2022.html
	^iii RSV in Older Adults and Adults with Chronic Medical Conditions. CDC. Accessed 7/11/22
	^iv Transmission of RSV (Respiratory Syncytial Virus). CDC. Accessed 7/11/22

SOURCE GlaxoSmithKline Inc.

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