Japan MHLW Accepts GSK's Arexvy Vaccine Application for Broader Adult Use
Japan's Ministry of Health, Labour and Welfare has accepted GSK plc's regulatory application to expand the use of its Arexvy RSV vaccine to adults aged 18-49 at increased risk of severe disease.
GSK plc announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted the company’s regulatory application to broaden the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 18-49 at increased risk of severe RSV disease.
If approved, GSK's vaccine would be the first available in Japan for this age group. Arexvy was previously approved in Japan for adults aged 60 and older and for adults aged 50 and older at increased risk for severe RSV disease.
The submission is supported by positive Phase IIIb trial data, which showed a comparable immune response in adults aged 18-49 at increased risk due to certain underlying medical conditions, to that observed in adults aged 60 and older. Safety and reactogenicity data were consistent with the Phase III program supporting the vaccine's initial approval.
RSV is a common respiratory virus that can cause severe illness, hospitalization, and death, particularly in vulnerable populations. Globally, it affects an estimated 64 million people of all ages annually and can exacerbate existing medical conditions.
This marks the first regulatory submission seeking approval for Arexvy for adults aged 18-49 at increased risk in Japan. GSK is also pursuing indication expansions for the vaccine in the US and Europe.