GSK’s Arexvy Gains the US FDA’s Approval for Expanded Age Indication to Prevent RSV Lower Respiratory Tract Disease
Shots:
- The US FDA has approved Arexvy (approved for >60yrs. individuals) for adults 50-59yrs. of age to prevent RSV lower respiratory tract disease (LRTD). Expecting decision from global regulatory bodies
- Approval was based on the P-III study assessing the safety & non-inferiority of the immune response in individuals (50 to 59yrs.) at high risk for RSV-LRTD vs adults (≥60yrs.) post single dose of the vaccine
- Additionally, results from the study assessing vaccine for its immunogenicity and safety in high risk individuals (18-49yrs.) and immunocompromised adults (≥18yrs.) are anticipated in H2’24
Ref: GSK | Image: GSK
Related News:- GSK Reports sBLA Acceptance of Arexvy Under Priority Review by the US FDA for Preventing RSV Disease
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
