GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk

GSK

6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile in this population.

GSK today announced that the US FDA has accepted under priority review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.

Read GSK press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Priority review , Dossier