Japan accepts GSK Arexvy regulatory application to prevent RSV disease in adults aged 50-59 at increased risk

This regulatory submission follows Japan’s approval of GSK’s vaccine for the prevention of RSV disease in adults from the age of 60 years, and the recent announcement of the positive results of a phase III trial [NCT05590403] evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV lower respiratory tract disease (LRTD) due to certain underlying medical conditions.

The burden of RSV disease in adults is likely to be underestimated due to lack of awareness and standardised testing, as well as under-detection within surveillance studies, but people with underlying medical conditions – such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure and diabetes– are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death. An international systematic review of the prevalence of respiratory viruses in patients with acute exacerbations of COPD, for example, showed that RSV was detected 1 in 10 cases.

Further announcements on regulatory progress in the US and EU are expected in early 2024.