FDA accepts review of GSK application to expand Arexvy RSV vaccine use
Investing.com
Published Jul 14, 2025 10:22AM ET
GSK plc (LSE/NYSE:GSK) announced Monday that the US Food and Drug Administration has accepted its application to review an expanded indication for its respiratory syncytial virus (RSV) vaccine, Arexvy. The application seeks approval for use in adults aged 18 to 49 who are at increased risk for severe RSV infection.
Arexvy is currently approved in the US for adults aged 60 and older, and for those 50 to 59 who are at increased risk. The company stated that more than 21 million US adults under age 50 have at least one risk factor for severe RSV infection, such as chronic obstructive pulmonary disease, asthma, congestive heart failure, or coronary heart disease.
The regulatory submission is supported by data from a Phase IIIb clinical trial that evaluated immune response and safety in adults aged 18 to 49 at increased risk, compared to adults aged 60 and above. According to the company, the safety and reactogenicity results were consistent with previous studies that supported the vaccine's initial approval.
A decision from the FDA on this expanded indication is expected in the first half of 2026.
GSK is also seeking expanded indications for Arexvy in other regions, including the European Economic Area and Japan.
Arexvy contains a recombinant RSV glycoprotein F antigen combined with GSK's proprietary AS01E adjuvant. The vaccine is approved for prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older in more than 60 countries, and for those aged 50 to 59 at increased risk in over 50 markets, including the US, Japan, and Europe.
This information is based on a press release statement included in a recent SEC filing.
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Written By: Investing.com
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