GSK’s Arexvy clears Japanese regulators for at-risk adults aged 18–59

GSK has won an expanded approval in Japan for its RSV vaccine Arexvy, with the country’s Ministry of Health, Labour and Welfare green-lighting use in adults aged 18 to 49 deemed at increased risk (AIR) of RSV disease. The decision makes Arexvy the first RSV vaccine cleared in Japan for the full sweep of at-risk adults — joining its existing authorizations covering everyone aged 60 and over, and at-risk adults in the 50–59 bracket. Alongside the age expansion, regulators have also updated the prescribing information to specifically name immunocompromised patients as an at-risk group, giving clinicians clearer guidance on who stands to benefit from vaccination.

Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases Research and Development, said: “This expanded approval, the first covering all at-risk adults in Japan, can help reduce potentially severe outcomes of RSV. It recognises the serious impact RSV can have for adults of any age living with chronic conditions such as cardiovascular disease, chronic obstructive pulmonary disease and asthma, and it enables more people to take a proactive approach to disease prevention.”

RSV is a common, highly contagious respiratory pathogen that can cause severe illness in adults — particularly those carrying underlying chronic conditions. Infection has been linked to major adverse cardiovascular events such as heart attack and stroke, can set off flare-ups of COPD and asthma, and may end in hospitalisation or death. Japan is home to more than 42 million adults aged 18–49, and although this group is typically viewed as lower-risk, a meaningful share live with chronic conditions that change the picture.

Regulatory clearance was anchored in a Phase IIIb trial showing that the vaccine generated a non-inferior immune response in at-risk 18- to 49-year-olds compared with the over-60 population, while efficacy itself rests on the earlier Phase III programme that underpinned the initial approval. The tolerability profile tracked with what has been seen across the broader Phase III work, with the most frequently reported reactions — injection-site pain, muscle aches, fatigue, joint pain and headache — largely short-lived and mild to moderate. The accompanying update naming immunocompromised patients as a risk group, accepted by Japan’s Pharmaceuticals and Medical Devices Agency, was supported by data from a separate Phase IIb study.

GSK said it is continuing to push regulatory filings for Arexvy in additional markets as it works to broaden access and bolster RSV prevention globally.

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