GSK plc announced that its regulatory application for Arexvy (Respiratory Syncytial Virus vaccine, [recombinant, adjuvanted), has been accepted for review by China's Center for Drug Evaluation (CDE) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older. If approved, Arexvy will be the first vaccine available to this population in China to help protect against the potentially serious consequences of RSV disease. 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 years in China (NCT06551181).
All primary endpoints were met and the vaccine has an acceptable safety profile. A regulatory decision is expected in 2027. RSV is estimated to affect more than six million adults aged 60 years and older in China annually, leading to over 350,000 RSV-related hospitalisations.
