GSK plc has made a step forward with its adjuvanted recombinant RSV vaccine, Arexvy, by submitting a regulatory application to the European Medicines Agency (EMA) for expanding its use to adults aged 50 to 59 years. If the application is approved, Arexvy would be the first RSV vaccine available for this particular age group, aiming to offer protection against RSV-associated lower respiratory tract disease in Europe.

Currently approved for use in individuals aged 60 and older in countries like the US, Europe, Japan, the UK, and Canada, Arexvy’s potential age indication expansion is supported by positive outcomes from a Phase III trial. This trial illustrated comparable immune responses in adults aged 50 to 59 to those observed in individuals aged 60 and above.

The trial, which was observer-blind, placebo-controlled, and randomized, analyzed the immune responses in participants aged 50 to 59 without pre-defined chronic diseases in comparison with adults aged 60 and older. The study successfully met its primary endpoints, demonstrating that RSV-A and RSV-B neutralization titers one month post-vaccination in the 50-59 age group were on par with those in the older cohort.

Tony Wood, GSK’s Chief Scientific Officer, commented on the trial’s findings, highlighting the potential of the RSV vaccine to extend protection to adults aged 50 to 59, particularly those at increased risk for RSV-LRTD due to certain health conditions. The trial reported that the safety and reactogenicity profile of the vaccine was in line with the initial phase III program findings, with the most common adverse events being mild, including pain, fatigue, and headache.

RSV is known for causing severe respiratory illness, especially among the elderly, immunocompromised individuals, or those with conditions like COPD, asthma, and chronic heart failure. By potentially extending the vaccine’s use to include the 50-59 age group, GSK aims to reduce the incidence of RSV-associated illness among these adults.

A decision by the European regulatory authority on this application is expected in the latter half of 2024. This initiative follows GSK’s strategic move to enhance its respiratory and inflammatory asset pipeline through the acquisition of Aiolos Bio for $1.4 billion.

The encouraging results from the Phase III trial [NCT05590403] were shared at the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, with plans to present final results at an upcoming medical conference and in a peer-reviewed publication. Additionally, these findings will be submitted to the FDA and other regulatory bodies to support the possible expansion of the vaccine’s label.

Arexvy combines recombinant glycoprotein F stabilized in the prefusion conformation with GSK’s proprietary AS01E adjuvant, marking a noteworthy development in the prevention of RSV. The vaccine’s current approval for older adults and the proposed extension to a younger age group underscore GSK’s ongoing efforts to address RSV prevention across a broader population.

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