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

GSK announced today approval by the US FDA of a label expansion for the adjuvanted respiratory syncytial virus (RSV) vaccine Arexvy that adds adults aged 50 to 59 years who are at elevated risk for RSV disease to the vaccine’s current indication.¹

Today’s extension follows the agency’s approval of Arexvy in May 2023 for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.2 The newly combined population, adults aged 50 to 60 years, represent individuals who may be at greater risk for RSV infection, particularly those with underlying medical conditions.

The decision makes Arexvy the first vaccine available to protect the younger age group from RSV-LRTD, according to GSK.¹

“Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50-59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD,” Tony Wood, chief scientific officer, GSK, said in a press release.¹

The FDA based its decision to expand the label on data from a late-stage clinical trial that GSK submitted as part of a supplemental biologics license application. The phase 3 study evaluated the safety and immunogenicity of Arexvy in adults aged 50 to 59 years with predefined stable chronic diseases, conditions that would increase the risk for RSV-LRTD (n = 570). The researchers also evaluated immune response in a broader group of participants in the same age group that did not have chronic disease (n = 570) and compared this group with adults aged 60 years and older.

The study met its primary endpoint of eliciting immune response among the cohort aged 50 to 59 years at high risk for RSV-LRTD that was noninferior to that observed in those aged 60 years and older, reported GSK in October 2023.³ Investigators observed the positive response among study participants in the younger age group with underlying conditions that included 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 the GSK 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

References

1. US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. News release. GSK. June 7, 2024. Accessed June 7, 2024. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-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