GSK wins FDA AdCom backing for RSV vaccine

Mar. 01, 2023 3:17 PM ETGSK plc (GSK)PFEBy: Dulan Lokuwithana, SA News Editor

An independent group of experts at the FDA voted unanimously on Wednesday in favor of Arexvy, a vaccine candidate developed by GSK (NYSE:GSK) against the respiratory syncytial virus (RSV).
After reviewing Phase 3 data, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) determined that Arexvy was effective in the prevention of RSV-linked lower respiratory tract disease (LRTD) in those aged 60 years and above.
On Tuesday, the same panel voted in favor of Abrysvo, another vaccine candidate developed by Pfizer (PFE), to prevent acute respiratory disease and LRTD caused by RSV in the same age group.
The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
Late last year, the FDA granted priority review for marketing applications for both Arexvy and Abrysvo expecting to issue a decision by May 2023.