05:52 AM EDT, 07/14/2025 (MT Newswires) -- GSK (GSK) said Monday that the US Food and Drug Administration has accepted its application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18 to 49 at higher risk.

The company said the vaccine is approved in the US for adults aged 60 and older and those aged 50 to 59 with increased risk.

The application is backed by a phase IIIb study comparing immune response and safety in the 18-49 age group to older adults, the company said, adding that the health agency is expected to decide in H1 2026.

GSK is also pursuing similar approvals in other regions, including the EU and Japan, it added.