GSK (LSE:GSK) said Japan's Ministry of Health, Labour and Welfare has expanded the approved population for its RSV vaccine Arexvy to include adults aged 18 to 49 years at increased risk for RSV disease.
The approval makes Arexvy the first RSV vaccine in Japan authorised for adults 18-59 years at increased risk and maintains approval for all adults 60 years and older.
"This expanded approval, the first covering all at-risk adults in Japan, can help reduce potentially severe outcomes of RSV," said Sanjay Gurunathan, Head of Vaccines and Infectious Diseases Research and Development at GSK.
The decision was supported by a Phase IIIb immunogenicity trial (NCT06389487) showing a non-inferior immune response in 18-49 at-risk adults versus those 60 and above, efficacy evidence from the earlier Phase III trial (NCT04886596), and Phase IIb data (NCT05921903) supporting the inclusion of immunocompromised patients.
GSK said the safety profile across the trials was consistent with its broader Phase III programme, with the most common adverse events being injection-site pain, myalgia, fatigue, arthralgia and headache, largely transient and mild-to-moderate.
GSK noted more than 42 million adults in Japan are aged 18-49 and that many in this group live with chronic conditions such as cardiovascular disease, COPD and asthma that elevate the risk of severe RSV outcomes including major adverse cardiovascular events, hospitalisation and death.
GSK said it will continue to advance regulatory submissions for Arexvy across multiple geographies to expand availability and support disease prevention.
