GSK PLC announced on Friday that Japan’s Ministry of Health, Labour & Welfare has accepted its regulatory submission to broaden the approved use of its respiratory syncytial virus (RSV) vaccine, Arexvy. The filing seeks to expand the vaccine’s indication to include adults aged 18 to 49 who are at increased risk of developing severe RSV-related illness.
The regulatory application is supported by positive results from a Phase 3B clinical trial, which demonstrated that adults in the 18-49 age group with certain underlying medical conditions achieved an immune response comparable to that observed in adults aged 60 and older, who are already eligible for the vaccine.
If approved, GSK would become the first company in Japan to offer an RSV vaccine for younger adults at heightened risk of serious RSV-related lower respiratory tract disease. RSV is a common respiratory virus that can cause serious illness in vulnerable populations, including not only older adults but also younger adults with chronic medical conditions.
In London trading on Friday morning, GSK shares remained steady at 1,435.00 pence, reflecting a market capitalization of approximately GBP 58.74 billion.