Japan Approves GSK’s Arexvy For At-Risk Adults Aged 50-59

GSK plc announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved an expanded indication for Arexvy, its adjuvanted recombinant RSV vaccine, to include adults aged 50-59 who are at increased risk of respiratory syncytial virus (RSV) disease. Previously, Arexvy was approved in Japan in September 2023 for adults aged 60 and older to prevent RSV.

"This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection. Adults aged 50-59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time,” said Tony Wood, Chief Scientific Officer at GSK

RSV is a highly contagious virus affecting the lungs and respiratory tract, impacting approximately 64 million people globally yearly. Adults at higher risk for severe RSV disease may have underlying conditions like COPD, asthma, chronic heart failure, a compromised immune system, or advanced age. RSV infections in these individuals can lead to complications such as pneumonia, hospitalisation, and even death.

The expanded approval is based on findings from a global Phase III trial, which included four clinical sites in Japan. The study demonstrated that adults aged 50-59 at higher risk of RSV-related lower respiratory tract disease achieved immune responses comparable to those aged 60 and older. Additionally, safety and tolerability in the 50-59 age group were consistent with initial Phase III trial results.

Arexvy is now approved for use in adults aged 50-59 at increased risk of RSV in 35 countries, including the United States, with regulatory reviews ongoing in other regions.