GSK secures EC approval for Arexvy vaccine for adults aged 50-59 at increased risk. (Credit: GSK plc)

GlaxoSmithKline (GSK) announced that the European Commission (EC) has approved Arexvy for active immunisation to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at higher risk.  

Arexvy is a recombinant adjuvanted vaccine for RSV combined with GSK’s proprietary AS01E adjuvant.

Individuals at increased risk due to underlying medical conditions, such as chronic obstructive pulmonary disease, asthma, heart failure, and diabetes, are eligible for Arexvy in Europe.

In June 2024, EC approved GSK’s RSV vaccine for preventing LRTD caused by RSV in individuals aged 60 and older.

In June, GSK received expanded approval from the US Food and Drug Administration (FDA) to use Arexvy in adults aged 50-59.

The latest approval by EC is backed by positive results from a Phase 3 trial that assessed the immune response and safety of GSK’s RSV vaccine in adults aged 50-59.

It also assessed those at increased risk for RSV-LRTD due to specific underlying medical conditions.

In the study, the vaccine achieved the primary endpoints, demonstrating effective neutralisation titres for both RSV-A and RSV-B in adults aged 50-59, comparable to those in adults aged 60 and above.

Additionally, Arexvy met the secondary and tertiary endpoints for safety and immunogenicity, with safety and reactogenicity data aligning with the results from the initial data read-out.

GSK chief scientific officer Tony Wood said: “Today’s approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk.

“RSV infection can have a significant impact on the health of older adults and particularly those with certain existing medical conditions, which can add pressure onto healthcare systems.”

Additionally, GSK has submitted regulatory applications to extend the use of this vaccine to adults aged 50-59 at increased risk in Japan and other regions, where decisions are currently under review.

Clinical trials assessing the vaccine’s immunogenicity and safety in adults aged 18-49 at increased risk, as well as in immunocompromised adults aged 18 and older, are expected to yield results later in 2024.