14th Jul 2025 08:21
(Alliance News) - GSK PLC on Monday said it has submitted a US regulatory application for the expanded use of its Arexvy respiratory syncytial virus vaccine.
The London-based drug maker said the US Food & Drug Administration has accepted for review an application to extend the indication of Arexvy to adults aged between 18 and 49 who are at "an increased risk".
The jab is currently approved in the US for the prevention of respiratory tract disease caused by RSV in adults aged 60 and older, and for those aged 50-59 who are most at risk.
The submission was supported by positive phase IIIb data showing immune response and safety results in adults aged 18-49 at increased risk compared to adults aged 60 and above.
The safety data were consistent with results from the phase III programme that supported the initial approval of the vaccine in the US.
"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," GSK said.
Shares in GSK rose 0.6% to 1,417.50 pence each in London on Monday morning. The wider FTSE 100 was up 0.2%.
By Jeremy Cutler, Alliance News reporter
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