GSK’s RSV Vaccine Moves Closer to China Approval
Regulatory filing for Arexvy has been accepted for review in China for adults aged 60 and older, where RSV affects millions each year
GSK's Arexvy, a recombinant and adjuvanted vaccine for respiratory syncytial virus (RSV), has received regulatory review acceptance from China's Center for Drug Evaluation for the prevention of lower respiratory tract disease in adults aged 60 and older. With RSV affecting over six million elderly adults in China annually and leading to more than 350,000 hospitalizations, this vaccine aims to address a significant health concern. Its development is backed by successful phase 3 clinical trial results, and if approved, Arexvy will be the first RSV vaccine available in China for this demographic, with a decision expected by 2027.
1. Arexvy vaccine is for RSV prevention in adults 60+. 2. Over 350,000 hospitalizations for RSV annually in China. 3. Positive phase 3 trial results support regulatory submission. 4. First RSV vaccine in China for this demographic if approved. 5. Vaccination necessary due to aging population's increased risk.