GSK said on Monday that the U.S. Food and Drug Administration has accepted for review its application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to at-risk adults aged 18 to 49.
The drugmaker said it anticipates a regulatory decision from the FDA in the first half of 2026.
The move follows the vaccine's U.S. approval for adults aged 60 and older, which was expanded in June 2024 to include at-risk individuals aged 50 to 59.
RSV is a common contagious virus that affects the lungs, and according to company data, more than 21 million U.S. adults under 50 have underlying conditions like asthma or heart disease that put them at higher risk of severe infection.
GSK said the application is supported by positive data from a late-stage trial that evaluated the vaccine's immune response and safety in the 18-to-49 age group.
The safety results were consistent with those from earlier studies that supported the vaccine's initial approvals, the company added.
The company is pursuing similar label expansions for Arexvy in Europe and Japan, where it recently submitted an application for the same younger adult population.
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