GSK has announced that its regulatory application for Arexvy (Respiratory Syncytial Virus [RSV] vaccine, [recombinant, adjuvanted]) has been accepted for review by China’s Center for Drug Evaluation (CDE). The submission seeks approval 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 would become the first vaccine available in China to help protect this age group from the potentially serious consequences of RSV disease. RSV is estimated to affect more than six million adults aged 60 and older in China each year, resulting in over 350,000 RSV-related hospitalizations.
The regulatory submission is supported by a robust clinical data package, including positive phase 3results from a trial in adults aged 60 and older in China (NCT06551181). The study met all primary endpoints and showed an acceptable safety profile. A regulatory decision is expected in 2027.
Arexvy contains recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3), combined with GSK’s proprietary AS01E adjuvant system. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The vaccine has been approved for the prevention of RSV-LRTD in adults aged 60 years and older in more than 65 countries. It is also approved for adults aged 50–59 at increased risk due to certain underlying medical conditions in more than 60 countries, including the US and Japan. In the European Economic Area, it is approved for adults aged 18 and older.
RSV in adults
RSV is a common contagious virus affecting the lungs and breathing passages, impacting an estimated 64 million people globally each year. Adults may face increased risk due to advanced age, immune-compromised status, or underlying health conditions.. Compared with children, adults hospitalized for RSV are at higher risk of severe complications, more costly treatments, and higher fatality rates, and the true burden may be underestimated due to lack of routine testing.
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