In a significant development, the European Commission has expanded the approval of Arexvy, GSK's respiratory syncytial virus (RSV) vaccine, to include adults aged 50-59 who are at heightened risk due to underlying health conditions.
This expanded age indication aims to protect approximately 20 million adults across 30 European countries who have medical conditions that increase their vulnerability to RSV-related lower respiratory tract disease (LRTD).
This authorization is timely, as it comes ahead of the upcoming RSV season, providing critical protection to a population that had not previously been covered. The expanded approval follows the vaccine's earlier authorization in the United States, with additional regulatory decisions expected in other countries, including Japan, later this year.
Arexvy had initially been approved in Europe in June 2023 for adults aged 60 and above to prevent RSV-induced LRTD. The vaccine is particularly crucial for individuals with chronic health conditions like chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes, which can significantly increase the risk of severe RSV complications. These complications can include pneumonia, hospitalization, and even death, especially in those with pre-existing health issues.
The European Union and European Economic Area are home to approximately 65 million adults aged 50-59, with an estimated 20 million of them having at least one condition that heightens their risk for RSV infection. The regulatory application for this expanded age group was bolstered by positive results from a phase III clinical trial that assessed both the immune response and safety profile of the vaccine in adults aged 50-59, including those at elevated risk due to underlying medical conditions.
Beyond the approvals in Europe and the United States, GSK has also submitted applications for regulatory approval to extend the use of Arexvy to at-risk adults aged 50-59 in Japan and other regions. The company is also conducting ongoing trials to evaluate the vaccine’s safety and efficacy in adults aged 18-49 who are at increased risk, as well as in immunocompromised adults aged 18 and older. Results from these trials are anticipated later in 2024.
Arexvy contains a recombinant RSV glycoprotein F, stabilized in its prefusion conformation (RSVPreF3), combined with GSK's proprietary AS01E adjuvant, designed to enhance the immune response.
The European Commission’s approval in June 2023 for individuals aged 60 and older was a critical step in providing protection against RSV-LRTD. As with all vaccines, it is essential to follow official recommendations, as not all recipients may develop a protective immune response.
Arexvy has also received approval for use in individuals aged 60 and above in 50 countries, including Europe, Japan, and the United States. Ongoing regulatory reviews are being conducted in several other countries. The final trade name for Arexvy remains subject to approval in these additional markets.
The AS01 adjuvant system used in Arexvy includes the QS-21 STIMULON adjuvant, which is licensed from Antigenics Inc., a wholly-owned subsidiary of Agenus.
Comments