GSK hoping to expand Arexvy usage in Japan
Japanese regulators have accepted 's application to expand the use of its RSV vaccine, Arexvy, to the entire adult population.
Arexvy is now being considered for those aged 18 to 49 who are at increased risk of severe RSV disease, following positive Phase IIIb data showing immune response and safety in this population.
The drug is already approved for those aged 60 and older for the prevention of RSV disease, and for those 50 and older at increased risk for severe RSV disease.
GSK announced on Friday that Japan's Ministry of Health, Labour and Welfare had accepted its regulatory application to expand the use.
Respiratory syncytial virus is a common, contagious virus that affects the lungs and breathing passages, impacting an estimated 64m people across the world each year. It can exacerbate certain medical conditions and lead to severe illnesses, and in some cases can be fatal.
"GSK is the first company to seek regulatory approval for the vaccine to help protect adults aged 18-49 at increased risk of severe RSV disease in Japan. Regulatory submissions to expand the indications for the RSV vaccine continue in other geographies including the US and Europe," GSK said in a statement.
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