GSK application for expanded RSV vaccine Arexvy use for adults 18-49 accepted for review by USFDA
London: GSK plc 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.
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. More than 125 million adults in the US are under 50 years of age. 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). RSV can exacerbate certain medical conditions and can also lead to severe illness resulting in hospitalisation, and even death.
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. 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.
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 use of this vaccine should be in accordance with official recommendations. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
The vaccine has been approved for the prevention of RSV-LRTD in individuals 60 years of age and older in more than 60 countries. In addition, it is approved for use in individuals aged 50-59 who are at increased risk in more than 50 markets, including the US, Japan and Europe.
The AS01 adjuvant system, owned by GSK, includes the QS-21 adjuvant, licensed by Antigenics, a wholly owned subsidiary of Agenus.
