GSK: FDA Accepts Application To Review Expanded Use Of RSV Vaccine, Arexvy

(RTTNews) - GSK plc (GSK, GSK.L) announced that the FDA has accepted for review an application to extend the indication of Arexvy or respiratory syncytial virus vaccine, adjuvanted to adults aged 18-49 who are at increased risk. GSK's RSV vaccine is approved in the US for the prevention of lower respiratory tract disease caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk. A regulatory decision by the FDA on the submission is expected in first half, 2026.

GSK said it is continuing to seek expanded indications for RSV vaccine in other geographies including in the European Economic Area and Japan.

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