GSK’s RSV vaccine Arexvy is accepted for regulatory review in China

GSK announces that its regulatory application for Arexvy has been accepted for review by China’s Center for Drug Evaluation for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 years and older.

Note that. the regulatory submission is based on the vaccine’s robust data package, including positive results from a Phase III trial evaluating the safety and immunogenicity of the vaccine in adults aged 60 years and older in China. In addition, all primary endpoints were met and the vaccine has an acceptable safety profile. A regulatory decision is expected in 2027.

 

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Related Topics and Keywords

arexvy, GSK, regulatory review, rsv