GSK plc (GSK.L) Tuesday said the US Food and Drug Administration (FDA) has accepted under priority review an application to extend the indication of GSK's respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.
A decision from the regulator is expected on June 7, 2024.
Arexvy is currently approved in the U.S. to prevent lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and more.
The application is supported by positive results from a phase III study evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to underlying medical conditions.
If approved, GSK's RSV vaccine will be the first vaccine available for this age group, the company said in a statement.
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