GSK (GSK) plc announced that the U.S. Food and Drug Administration has accepted for review an application to extend the indication of Arexvy 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. This regulatory submission is supported by a phase IIIb trial evaluating immune response and safety in adults aged 18-49 at increased risk compared to adults aged 60 and above.6 The safety and reactogenicity data were consistent with results from the phase III program that supported the initial approval of the vaccine in the U.S. A regulatory decision by the FDA on this submission is expected in H1 2026. GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic Area and Japan.
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