GSK (NYSE:GSK) announced today that the US Food and Drug Administration (FDA) has approved Arexvy, an adjuvanted Respiratory Syncytial Virus (RSV) vaccine, for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50 to 59 who are at increased risk.

This marks an expansion from its current approval for use in adults aged 60 and older.

“Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk,” stated Tony Wood, Chief Scientific Officer at GSK.

Some 42,000 hospitalizations occur annually in the US among adults aged 50-64 due to RSV, with those having underlying conditions like COPD, asthma, heart failure, and diabetes at higher risk for severe outcomes.

GSK has also filed regulatory submissions to extend the use of its RSV vaccine to adults aged 50-59 at increased risk in Europe, Japan, and other geographies, with regulatory decisions undergoing review.