GSK’s Arexvy Gains the US FDA’s Approval for Expanded Age Indication to Prevent RSV Lower Respiratory Tract Disease


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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