GSK plc (GSK.L) Thursday announced positive preliminary data from two studies evaluating its respiratory syncytial virus vaccine (RSV), Arexvy in adults aged 18-49 who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV due to certain underlying medical conditions and in adults who are immunocompromised.
In the Phase 3b study, a single dose of the vaccine elicited robust immune responses in adults aged 18-49 who are at increased risk for RSV-LRTD. The immune response was non-inferior to that observed in adults aged 60 and above, meeting the trial's co-primary endpoints.
The vaccine also showed robust immune response in immunocompromised adults in Phase 2b study. In this group, a second dose of vaccine elicited immune responses similar to those of healthy adults aged 50 and older who received one dose. These immune responses were consistent for RSV-A and RSV-B subtypes in all groups.
The company plans to submit final data from these studies to the Food and Drug Administration (FDA) and other regulators to support potential label updates.
The vaccine is currently approved for use in adults aged 60 and above in over 50 countries, and in adults aged 50-59 at increased risk in a number of countries including the US and Europe.
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