The U.S. Food and Drug Administration (FDA) has initiated a priority review of GlaxoSmithKline’s (GSK; NYSE: GSK) application to extend the age range for its respiratory syncytial virus (RSV) vaccine, Arexvy, to include individuals aged 50 to 59 who are at increased risk for RSV disease. Arexvy was previously approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and older.
The FDA aims to make a decision by June 7, 2024, following an evaluation of a late-stage trial that successfully met its primary endpoints, demonstrating comparable RSV-A and RSV-B neutralization titers against a control group of older adults.
GSK is leveraging a priority review voucher from the FDA to expedite Arexvy’s availability for this younger demographic, positioning itself ahead of potential competitors in the market.- Flcube.com
