GSK's Arexvy RSV Vaccine Gets FDA's Approval For Adults Aged 50-59

(RTTNews) - GSK plc (GSK, GSK.L) announced Monday that the US Food and Drug Administration has approved Arexvy, Respiratory Syncytial Virus or RSV Vaccine, Adjuvanted, to prevent RSV lower respiratory tract disease or LRTD in adults 50 through 59 years of age who are at increased risk.

RSV is a common contagious virus affecting the lungs and breathing passages. Arexvy is the first RSV vaccine for adults in this age group.

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.

GSK further said it has 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.

The approved expanded age indication for GSK's Arexvy in the U.S. was supported by positive results from phase III NCT05590403 trial 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.

The results were presented at the ACIP meeting of October 2023 and at ReSVinet in February 2024, and have been submitted for peer-reviewed publication.

The data are being submitted to other regulators to support potential label expansions.

It was in May 2023 that the FDA approved GSK's RSV vaccine for the prevention of LRTD caused by RSV in individuals 60 years of age and older.

So far, 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.

The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.

The company further said the 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 the second half.

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