GSK plc (LON/NYSE:) has announced that the US Food and Drug Administration (FDA) has approved 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 US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.
· Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes[1]
· Clinical development programme continues to evaluate safety and immunogenicity in adults 18+ with data read-outs expected H2 2024
A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalisations* each year in adults aged 50-64 years old.[2] Adults with underlying medical conditions, such as chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes[3] 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, hospitalisation or death.[4]
*adjusted for under-detection
Tony Wood, Chief Scientific Officer, GSK, said: “Today’s approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”
The regulatory application was supported by positive results from a phase III trial [NCT05590403][5] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions.
Professor Ann R. Falsey, University of Rochester School of Medicine, said: “I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider. Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them.”
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. Trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are expected to read out in H2 2024.
