GSK plc (GSK, GSK.L) announced on Monday that the US Food and Drug Administration (FDA) has approved Arexvy, an adjuvanted Respiratory Syncytial Virus (RSV) vaccine, for preventing RSV lower respiratory tract disease (LRTD) in adults aged 50 to 59 who are at increased risk.
RSV, a prevalent virus that affects the lungs and airways, now has its first vaccine for adults within this age category. In the United States, the vaccine is already approved for adults aged 60 and above and is recommended by the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) through shared clinical decision-making.
GSK has also filed regulatory submissions to extend the vaccine's use to adults aged 50 to 59 at increased risk in Europe, Japan, and other regions, with regulatory reviews ongoing.
The expanded age indication in the US is supported by positive phase III trial (NCT05590403) results, which evaluated the immune response and safety of GSK's RSV vaccine in adults aged 50 to 59, including those with underlying medical conditions that heighten their risk for RSV-LRTD. These findings were presented at the ACIP meeting in October 2023 and the ReSVinet conference in February 2024, and have been submitted for peer-reviewed publication.
The trial data is also being submitted to other regulatory bodies to support potential label expansions.
In May 2023, the FDA originally approved GSK's RSV vaccine for preventing LRTD caused by RSV in individuals aged 60 and over. The vaccine has since been approved in over 40 countries, including Europe, Japan, and the US, for individuals in the same age group.
GSK's proprietary AS01 adjuvant system, used in the vaccine, contains the STIMULON QS-21 adjuvant, which is licensed from Antigenics Inc., a wholly owned subsidiary of Agenus Inc.
GSK also announced that trials assessing the immunogenicity and safety of the vaccine in adults aged 18 to 49 who are at increased risk, as well as in immunocompromised adults aged 18 and over, are anticipated to conclude in the second half of the year.
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