- Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
- The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
- US launch is planned before the 2023/24 RSV season
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.
Tony Wood, Chief Scientific Officer, GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”