Health Canada approves Arexvy to prevent respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD) in people aged 60 years and above.- GSK
Health Canada has granted approval for GSK’s Arexvy vaccine to prevent respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD) in people aged 60 years and above. A recombinant, AS01E-adjuvanted RSV vaccine, Arexvy is the first to obtain approval for use in older adults in the country.
The approval was based on the findings from a Phase III clinical trial programme in which Arexvy demonstrated 82.6% efficacy in preventing LRTD in older subjects. The vaccine also demonstrated an efficacy of 94.6% in individuals with underlying medical issues. Arexvy was found to be well-tolerated with a suitable safety profile. Pain at the injection site, fatigue, myalgia and headache were among the most reported adverse events in the trials. The company anticipates making Arexvy available in the country before the 2023-2024 peak RSV season.
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