By VETTAPHARMA reporter: GSK plc (LSE/NYSE: GSK) has announced that its regulatory application for the Respiratory Syncytial Virus (RSV) vaccine Arexvy (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 RSV in adults aged 60 years and older. If approved, Arexvy would be the first vaccine available in China for this indication in this age group.
The submission is supported by a robust data package that includes positive results from a Phase III trial (NCT06551181) conducted in adults aged 60 years and older in China. All primary endpoints were met, and the vaccine demonstrated an acceptable safety profile. A regulatory decision from the CDE is expected in 2027.
RSV is a common contagious virus affecting the lungs and breathing passages. In China, it is estimated to affect more than six million adults aged 60 and older annually, leading to over 350,000 RSV-related hospitalisations each year.
Arexvy contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant. As with all vaccines, a protective immune response may not occur in every vaccinee.
Globally, Arexvy has been approved for the prevention of RSV-LRTD in individuals aged 60 and older in more than 65 countries, and for adults aged 50–59 years who are at increased risk due to certain underlying medical conditions in more than 60 countries, including the United States and Japan. In the European Economic Area (EEA), it is approved for adults aged 18 years and older.
Source credit:
- GSK plc. (2026, February 10). GSK’s RSV vaccine, Arexvy, accepted for regulatory review in China for adults aged 60 years and older. Click here
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