Summary by Moomoo AI
GSK announced Japan's approval of Arexvy, its RSV vaccine, for adults aged 50-59 at increased risk of severe RSV disease. This expansion, effective November 22, 2024, makes Japan the 35th country to approve the vaccine for this at-risk population. Arexvy was previously approved in Japan for adults 60 and over in September 2023.The approval was based on a global phase III trial showing non-inferior immunogenicity in the 50-59 at-risk group compared to those 60 and older. Safety and reactogenicity were consistent with results from the initial phase III program. RSV affects an estimated 64 million people globally annually, with adults at increased risk due to certain underlying conditions facing severe outcomes like pneumonia and hospitalization.GSK's Chief Scientific Officer, Tony Wood, emphasized the company's commitment to protecting at-risk individuals from severe RSV consequences. The vaccine contains recombinant RSV glycoprotein F and GSK's proprietary AS01E adjuvant. GSK continues to seek regulatory approvals for Arexvy in other geographies.