GSK's RSV Vaccine Gains FDA Approval for At-Risk Adults 50-59

The FDA has granted an expansion for the use of GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, now allowing its administration to adults aged 50 to 59 who have medical conditions that elevate their risk of severe outcomes. This expansion permits the vaccine's usage for preventing lower respiratory tract disease (LRTD) linked to RSV in this younger age group. Previously, Arexvy was approved in May 2023 for adults aged 60 and older, making it the first RSV vaccine to receive FDA approval.

The recent label expansion is supported by data from a Phase III clinical trial examining the vaccine's immunogenicity and safety in the 50-59 age subgroup. GSK had shared preliminary results from this study in October 2023, demonstrating that Arexvy evokes a comparable immune response in this younger demographic.

According to Tony Wood, GSK’s Chief Scientific Officer, the approval highlights the significance of expanding access to Arexvy for older adults at increased risk. Wood emphasized the severe consequences RSV can have on individuals with underlying health conditions and expressed pride in providing protection against RSV-LRTD for these vulnerable populations.

Arexvy's application for this younger age group is also under review in Europe, Japan, and other regions. Additionally, GSK is exploring the vaccine's effectiveness in adults aged 18 to 49 at high risk of severe disease and in immunocompromised individuals aged 18 and older. The outcomes of these studies are anticipated in the latter half of the year.

This expansion helps GSK solidify its lead in the RSV vaccine market. Arexvy's initial FDA approval in May 2023 positioned it ahead of its main competitor, Pfizer's Abrysvo, which received approval a month later. 

In December 2023, GSK’s CEO Emma Walmsley expressed satisfaction with Arexvy's market performance, projecting over £1 billion in sales during its first commercial year. Walmsley indicated significant growth potential for the vaccine.

In its initial commercial quarter, Arexvy captured approximately two-thirds of retail RSV vaccinations in the United States, generating nearly $859 million in revenue. In contrast, Pfizer’s Abrysvo reported significantly lower sales of $375 million during the same period.

CFO David Denton acknowledged at a November 2023 investor event that Pfizer's market share had not met expectations, yet expressed confidence in improved future performance.

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