GSK reports preliminary data for AREXVY

GSK (GSK) announced new preliminary data for AREXVY in adults aged 18-49 at increased risk for lower respiratory tract disease, LRTD, caused by respiratory syncytial virus due to certain underlying medical conditions and in adults who are immunocompromised. These data show the vaccine’s potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV. In the US alone, the number of adults aged 18-49 with at least one risk factor that could put them at risk for RSV disease could exceed 21 million. In the phase IIIb trial a single dose of the vaccine elicited robust immune responses in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions. The immune response was non-inferior to that observed in adults aged 60 and older, meeting the trial’s co-primary endpoints. In the phase IIb trial a single dose of the vaccine showed a robust immune response in adults aged 18 and older who are immunocompromised due to kidney or lung transplant, with a second dose eliciting 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. In both studies, the safety and reactogenicity data were consistent with results from the phase III program that have supported the initial approval of the vaccine.