GSK Submits Arexvy for Expanded Adult Use to FDA
Why we think this is neutral
This RNS announcement provides an update on GSK's regulatory submission for its RSV vaccine Arexvy to expand the indication to adults aged 18-49 at increased risk. While this is positive progress, the announcement does not contain any financial figures, contract details, or other quantifiable metrics that would warrant a stronger sentiment score.
Key Points
- GSK has submitted an application to the FDA to expand the indication of its RSV vaccine Arexvy to include adults aged 18-49 at increased risk
- The submission is supported by positive Phase IIIb trial data showing immune response and safety in the younger adult population
- A regulatory decision from the FDA is expected in H1 2026
Summary
GSK has submitted an application to the FDA to expand the indication of its RSV vaccine Arexvy to include adults aged 18-49 who are at increased risk. The vaccine is currently approved for adults aged 60 and older, as well as those aged 50-59 at increased risk. The submission is supported by positive Phase IIIb trial data showing immune response and safety in the younger adult population. A regulatory decision is expected in H1 2026.