Submission supported by positive results of a Phase III study showing immune response and safety in adults aged 50-59
RSV virus. (Credit: GSK plc)
GSK today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review a regulatory application to extend the indication of GSK’s respiratory syncytial virus (RSV) vaccine (recombinant adjuvanted) for the prevention of 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 studies1, but people with underlying medical conditions – such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure2 and diabetes3– are at increased risk for RSV disease. RSV can exacerbate these conditions and lead to pneumonia, hospitalisation, or death.4 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.5
GSK is the first company to seek regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease. Further announcements on regulatory progress in the US and EU are expected in early 2024.
Source: Company Press Release