GSK Reports sBLA Acceptance of Arexvy Under Priority Review by the US FDA for Preventing RSV Disease
Shots:
- The US FDA has accepted sBLA, under priority review, to expand the indication of Arexvy (RSV vaccine) to adults (50-59yrs.) with an increased risk for RSV disease. The decision is anticipated on Jun 07, 2024
- The application was based on the P-III study investigating Arexvy’s safety and non-inferiority of the immune response in patients (n=570; 50-59yrs.) with a high risk of lower respiratory tract disease caused by respiratory syncytial virus (RSV-LRTD) vs adults (60yrs. & above) after a single dose of RSV vaccine
- Arexvy, combined with AS01E adjuvant, contains recombinant glycoprotein F stabilized in the prefusion conformation (RSVPreF3). It is approved for adults, 60yrs. & older, to prevent RSV-LRTD in the US
Ref: GSK | Image: GSK
Related News:- GSK Reports the Acceptance of the Regulatory Application for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Related Diseases
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
