By Fineline Cube 
UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) seeking to expand the use of its adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy to adults aged 18-49 years at high risk for RSV infection. A regulatory decision is anticipated in the first half of 2026.
Current Approval and Indications
Arexvy is already approved in the US for the prevention of RSV-associated lower respiratory tract disease (LRTD) in adults ≥60 years and adults aged 50–59 years at increased risk. This new application aims to broaden its use to younger high-risk populations.
Phase IIIb Trial Results
A Phase IIIb trial has demonstrated comparable immunogenicity and safety profiles of Arexvy in high-risk 18–49-year-olds and adults ≥60 years. These results support the potential expansion of the vaccine’s indications to cover a wider range of patients at risk for RSV infection.-Fineline Info & Tech