GSK’s Arexvy FDA review accepted for adults 18-49 at increased risk

GSK plc (LON/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk. GSK’s RSV vaccine is approved in the US for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 and older, and for those aged 50-59 years who are at increased risk.

US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk:

·   More than 21 million US adults under the age of 50 have at least one risk factor for severe RSV infection¹

·   Submission supported by positive Phase IIIb data showing immune response and safety results in this population

·   FDA decision anticipated H1 2026

RSV is a common contagious virus affecting the lungs and breathing passages and impacts an estimated 64 million people of all ages globally every year.² More than 125 million adults in the US are under 50 years of age.¹ An estimated 21 million of these people have at least one diagnosed risk factor for severe RSV infection, such as chronic obstructive pulmonary disease (COPD), asthma, congestive heart failure and coronary heart disease (CHD).¹ RSV can exacerbate certain medical conditions and can also lead to severe illness resulting in hospitalisation, and even death.^{3 4 5}

This regulatory submission is supported by a phase IIIb trial evaluating immune response and safety in adults aged 18-49 at increased risk compared to adults aged 60 and above.⁶ The safety and reactogenicity data were consistent with results from the phase III programme that supported the initial approval of the vaccine in the US.

A regulatory decision by the FDA on this submission is expected in H1 2026.

GSK is continuing to seek expanded indications for its RSV vaccine in other geographies including in the European Economic Area and Japan.

References:

1. E.Horn et al, “Characteristics Associated with the Presence of One or More Risk Factors for Severe Respiratory Syncytial Virus Disease among Adults in the United States”, poster presented at ID Week 2024 [available on demand: P691 – DV-009542.pdf]
2. National Institute of Allergy and Infectious Diseases, Respiratory Syncytial Virus (RSV). Available at: https://www.niaid.nih.gov/diseases-conditions/respiratory-syncytial-virus-rsv Accessed June 2025
3. McLaughlin JM, Khan F, Begier E, et al. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis.
4. Atamna A, Babich T, et al. Morbidity and mortality of respiratory syncytial virus infection in hospitalized adults: Comparison with seasonal influenza. Int J Infect Dis. 2021 Feb;103:489-493. doi: 10.1016/j.ijid.2020.11.185.
5. Falsey, AR et al. Respiratory syncytial virus infection in elderly and high-risk adults, in New Engl J Med 2005; 352:1749-59. doi: 10.1056/NEJMoa043951
6. Clinicaltrials.gov, “A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above” – available at: https://clinicaltrials.gov/study/NCT06389487