GSK's Arexvy approved for wider age range in Japan

Biopharma giant GSK has announced that Japanese regulators have expanded the approved use of its Arexvy vaccine for severe respiratory syncytial virus (RSV) disease to a wider age range.

Arexvy, which from September 2023 had been approved in Japan for adults 60 and over for the prevention of RSV disease, can now be administered to 50-59 year olds, according to the Ministry of Health, Labour and Welfare.

Japan was the 35th country that the vaccine has been approved for us in the 50-59 age range, with regulatory decisions for other geographies undergoing review.

"This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection," said GSK's chief scientific officer Tony Wood.

"Adults aged 50-59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time."

RSV, a common virus affecting the lungs and breathing passages, is estimated to affect 64m people globally every year, with older adults at increases risk due to certain underlying medical conditions, immune compromised status, or advanced age.

The age expansion in Japan was supported by results from a global phase III trial, with safety and reactogenicity in the at-risk 50-59 group consistent with results from trials of those 60 and older.