GSK wins FDA nod to expand label for RSV vaccine

Ildar Imashev GSK ( NYSE: GSK ) announced late Friday that the U.S. FDA approved Arexvy, its vaccine against the respiratory syncytial virus (RSV) for adults aged 50–59 years at increased risk of infection, expanding its current label for older adults.

With the decision, the British drugmaker moves past Pfizer ( PFE ) and Moderna ( MRNA ), its rivals in the RSV vaccine space, in widening access to Arexvy, which contains an adjuvant licensed from Agenus ( NASDAQ: AGEN ). Last year, GSK ( GSK ), as well as Pfizer ( PFE ), received FDA approval to market their RSV vaccines, Arexvy and Abrysvo, for people 60 years of age and older to prevent the lower respiratory tract disease (LRD) caused by the virus. Just last week, Moderna ( MRNA ) announced that the agency cleared its messenger-RNA-based vaccine mRESVIA to prevent RSV-linked LRD in the same age group.

GSK ( GSK ) said European, Japanese, and other regulators are also conducting reviews to expand the use of its RSV shot for at-risk adults aged 50–59 years. The company expects results from trials testing Arexvy in at-risk adults aged 18–49 and immunocompromised adults aged 18 and older in H2 2024. More on GSK, Agenus, etc.

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