US FDA expands approval to GSK’s Arexvy for adults aged 50-59, at increased risk

GSK announced that the US FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 to 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.  

A systematic review of studies in the US showed that RSV is estimated to cause 42,000 hospitalisations (1) 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)

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. 

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.   

Respiratory Syncytial Virus Vaccine, Adjuvanted, contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with GSK’s proprietary AS01E adjuvant.  The vaccine has also been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in over 40 countries, including Europe, Japan and US. Regulatory reviews in multiple countries are ongoing. The proposed trade name remains subject to regulatory approval in other markets. 

References:

1. Horn et al, “Disparities in Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, Abstract presented at National Foundation for Infectious Diseases – 27th Annual Conference on Vaccinology Research – NFID 2024; May 8-10, 2024
2. McLaughlin JM et al, “Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis” in Open Forum Infectious Diseases, Volume 9, Issue 7, July 2022
3. Branche AR et al., « Incidence of Respiratory Syncytial Virus Infection Among Hospitalized Adults, 2017–2020” in Clinical Infectious Diseases, 2022:74:1004–1011
4. Centers for Disease Control and Prevention (CDC), RSV in Older Adults and Adults with Chronic Medical Conditions, 2024
5. ClinicalTrials.gov, A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above 2023. NCT05590403.