Therapy Areas: Vaccines
GSK seeks US approval for RSV vaccine in at-risk adults aged 50-59
6 February 2024 -

Biopharmaceutical company GSK plc (LSE/NYSE: GSK) announced on Tuesday that the US Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of its adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease.

Positive phase III trial results support the application, demonstrating immune response and tolerability in this demographic. If approved, GSK's RSV vaccine would be the first vaccine available to help protect this group.

Arexvy is currently approved in the United States in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

The Prescription Drug User Fee Act date for the FDA's decision is 7 June 2024.

The burden of RSV disease in adults, particularly those with conditions like COPD and asthma, is significant, with potential severe consequences such as pneumonia, underscoring the critical need for preventive measures.