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GSK RSV Vaccine Arexvy Under FDA Priority Review for Prevention of RSV in High-Risk Adults Aged 50 to 59 Years


Approval of the application would extend the current Arexvy indication for prevention of RSV is adults aged 60 years and older; a June 2024 PDUFA date is set.

The adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy (GSK) has been accepted for US Food and Drug Administration (FDA) priority review for a label expansion that would add adults aged 50 to 59 years who are at elevated risk for RSV disease to the vaccine’s current indication, GSK announced this week.1

The FDA approved Arexvy in May 2023 for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.2 Combined the 2 age groups represent individuals who may be at greater risk for RSV infection, particularly those with underlying medical conditions. If approved, the vaccine would be the first available to protect the younger age group.1

The FDA has set a PDUFA date of June 7, 2024, according to the GSK statement.1

GSK RSV Vaccine Arexvy Under FDA Priority Review for Prevention of RSV in High-Risk Adults Aged 50 to 59 Years / image credit GSK logo: ©desertlands/stock.adobe.com

The GSK supplemental biologics license application is supported by a late-stage clinical trial that evaluated the safety and immunogenicity of Arexvy in adults aged 50 to 59 years, including those with medical conditions that that would increase the risk for RSV-LRTD.3

The study met its primary endpoint of eliciting immune responses among the cohort aged 50 to 59 years at high risk for RS- LRTD that was noninferior to that observed in those aged 60 years and older, reported GSK in October 2023.3 The positive response was observed among study participants with underlying conditions including chronic obstructive pulmonary disease, cardiovascular disease, kidney disease, liver disease or diabetes.3

The findings were comparable among the 50- to 59-year-old participants who were not at increased risk for infection.3

GSK said at the time that data on safety and reactogenicity for all participants in the trial were consistent with those from the initial phase 3 program. Pain at the injection site was reported as the most common local adverse event (AE); the most common systemic AEs, fatigue, and headache, were reported as mild and transient.3

The original application for approval of Arexvy in adults aged 60 years and older was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed 82.6% overall efficacy against RSV-LRTD in this age group.3 With that approval the GSK vaccine became the world’s first against RSV in any population.2

1. GSK’s RSV vaccine, AREXVY, accepted under Priority Review in US for the prevention of RSV disease in adults aged 50-59 at increased risk. News release. GSK. February 6, 2024. Accessed February 8, 2024. https://us.gsk.com/en-us/media/press-releases/gsk-s-rsv-vaccine-arexvy-accepted-under-priority-review-in-us-for-the-prevention-of-rsv-disease-in-adults-aged-50-59-at-increased-risk/
2. Halsey G. FDA approves world’s first vaccine against respiratory syncytial virus. Patient Care. May 3, 2023. Accessed February 8, 2024. https://www.patientcareonline.com/view/fda-approves-world-s-first-vaccine-against-respiratory-syncytial-virus
3. Halsey G. Immune responses to Arexvy in adults aged 50 to 59 years noninferior to those in adults aged 60 years and older. Patient Care. October 30, 2023. Accessed February 8, 2024. https://www.patientcareonline.com/view/immune-responses-to-arexvy-in-adults-aged-50-to-59-years-noninferior-to-those-in-adults-aged-60-years-and-older

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