GSK's RSV Vaccine Arexvy Accepted for Priority Review in US for Adults Aged 50-59
The US Food and Drug Administration (FDA) has accepted GSK's Arexvy vaccine application for priority review to extend its use to adults aged 50-59 at increased risk of RSV disease.
GSK plc announced on February 6, 2024, that the US Food and Drug Administration (FDA) has accepted an application for priority review for its Arexvy respiratory syncytial virus (RSV) vaccine. The application seeks to extend the vaccine's indication to adults aged 50-59 who are at increased risk for RSV disease. If approved, Arexvy would be the first vaccine available to help protect this population.
Arexvy is currently approved in the US for adults aged 60 and over for the prevention of lower respiratory tract disease caused by RSV. The new application is supported by positive results from a Phase III trial demonstrating immune response and acceptable tolerability in the 50-59 age group. The FDA's decision, under the Prescription Drug User Fee Act, is expected by June 7, 2024.
RSV disease in adults can exacerbate underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure, and diabetes, potentially leading to pneumonia, hospitalization, or death. GSK is the first company to seek regulatory approval to extend RSV vaccination to this at-risk population.
GSK is a global biopharma company focused on uniting science, technology, and talent to get ahead of disease. The company is awaiting regulatory decisions from other authorities regarding potential label expansions.