GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk [Yahoo! Finance]
Agenus Inc. (AGEN)
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Source: Yahoo! Finance
Adults aged 50 and above with underlying medical conditions are at increased risk for RSV disease GSK is the first company to seek regulatory approval to extend RSV vaccination to this population MISSISSAUGA, ON Feb. 26, 2024 /CNW/ - 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. 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
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