Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a regulatory application to extend the indication of GSK’s Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV disease to include adults aged 50-59 at increased risk. Since September 2023, GSK’s RSV vaccine has been approved in Japan for adults aged 60 and over for the prevention of RSV disease.
Tony Wood, Chief Scientific Officer at GSK, said: “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.”
RSV is a common contagious virus affecting the lungs and breathing passages and it impacts an estimated 64 million people of all ages globally every year. Adults can be at increased risk for RSV disease due to certain underlying medical conditions, immune compromised status, or advanced age. RSV infection can exacerbate conditions, including COPD, asthma, and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death.
This regulatory expansion was supported by results from a global phase III trial (including 4 clinical sites in Japan) that showed non-inferior immunogenicity in adults aged 50-59 at increased risk of RSV lower respiratory tract disease compared to those aged 60 and older. Safety and reactogenicity in the 50-59 at increased risk population were consistent with results from the initial phase III programme in adults aged 60 and older.
To date, GSK’s RSV vaccine has been approved for adults aged 50-59 at increased risk in 35 countries, including the US, with regulatory decisions for other geographies undergoing review.
