GSK closer to Japanese Arexvy label expansion

Japan’s Ministry of Health, Labor and Welfare (MHLW) has accepted UK pharma major GSK’s (LSE: GSK) regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults aged 18 to 49 years at increased risk of severe RSV disease.

Arexvy was the first vaccine approved in Japan for adults aged 60 years and older for the prevention of RSV disease, and for those aged 50 years and older at increased risk for severe RSV disease.

The London-based drugmaker’s regulatory submission to the MHLW is supported by positive results from a Phase IIIb trial, which showed a non-inferior immune response in adults aged 18 to 49 years at increased risk for RSV-LRTD due to certain underlying medical conditions, to that observed in adults aged 60 and above.