UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expansion of the indication for Arexvy to include adults aged 50-59 who are at an increased risk of respiratory syncytial virus (RSV) infection. This marks a significant step in broadening the vaccine’s accessibility to a wider demographic within Japan.
Previous Approvals and Current Expansion
The adjuvanted RSV vaccine, Arexvy, had previously received marketing approval in Japan for adults aged 60 and over for the prevention of RSV disease. This latest approval by the MHLW extends the vaccine’s potential patient base to include an older adult population that is still at significant risk but has not yet reached the age of 60.
Global Approvals and Recommendations for Arexvy
Arexvy was granted approval in the US in May 2023 for the prevention of lower respiratory tract diseases (LRTD) caused by RSV infection in individuals aged 60 and above. This indication was later extended in June to include adults aged 50-59 in the US, and in July, the vaccine was recommended for approval in the European Union (EU), further highlighting the global recognition of its importance in RSV prevention.-Fineline Info & Tech
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