GSK’s Arexvy gains expanded approval from FDA

The US Food and Drug Administration (FDA) has approved UK pharma major GSK’s (LSE: GSK) Arexvy (respiratory syncytial virus [RSV] vaccine, adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk.

In the USA, the vaccine is currently approved for use in adults aged 60 and older and recommended by the US Centers for Disease control and Prevention (CDC)/ Advisory Committee on Immunization Practices (ACIP) using shared clinical decision-making.

A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old. Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetlles are at increased risk for severe consequences from an RSV infection compared to those without these conditions. RSV can exacerbate these conditions and lead to pneumonia, hospitalization or death.