GSK Submits Regulatory Application to Expand Arexvy RSV Vaccine Use to High-Risk Adults Aged 50–59 in Europe

On January 29, GSK announced that the European Medicines Agency (EMA) has accepted a regulatory application to expand the eligibility of its recombinant respiratory syncytial virus (RSV) vaccine Arexvy to include high-risk adults aged 50-59. The EMA is expected to make a decision in the second half of 2024. If approved, Arexvy would become the first RSV vaccine available to protect this population.

Arexvy has been approved for marketing in the United States and Europe in 2023, respectively, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and above.

This regulatory submission is based on positive results from a Phase III placebo-controlled, randomized study (NCT05590403). The trial aimed to evaluate the non-inferiority and safety of immune responses in participants aged 50-59 with an increased risk of RSV-LRTD and in elderly adults aged 60 years and older following a single dose of Arexvy.

The results showed that the immune response in the 50-59 age group was non-inferior to that in the 60 and above age group, reaching the primary endpoint. In addition, the study also achieved secondary and tertiary endpoints for safety and immunogenicity.

In the RSV vaccine sector, only GSK's Arexvy and Pfizer's Abrysvo have been approved for marketing. These two products quickly gained traction upon their launch, with sales revenue growing rapidly. As the first marketed RSV vaccine, Arexvy generated Q3 revenues of £709 million ($880 million); closely following, Abrysvo also performed well, achieving Q3 sales of $375 million.

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