GSK plc's Arexvy Vaccine Receives Expanded Approval in Japan

GSK plc announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has expanded the eligible population for its RSV vaccine, Arexvy, to include adults aged 18 to 49 years at increased risk for RSV disease. Previously, the vaccine was approved in Japan for adults aged 60 and older, and for those aged 50-59 at increased risk. The prescribing information has also been updated to explicitly include immunocompromised patients as an increased risk group. This expanded approval marks the first time a RSV vaccine in Japan covers all at-risk adults, regardless of age. The decision was supported by data from Phase IIIb and Phase IIb trials, demonstrating comparable immune responses and a consistent safety profile. Arexvy contains recombinant RSV glycoprotein F and GSK's proprietary AS01E adjuvant. The company continues to seek regulatory approvals in other regions to broaden access to the vaccine.