GSK has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) to prevent respiratory syncytial virus (RSV) disease in adults aged 60 years and above.
Arexvy consists of recombinant glycoprotein F stabilised in the prefusion conformation (RSVPreF3). This antigen is combined with the AS01E adjuvant of GSK.
The GSK AS01 adjuvant system includes STIMULON QS-21 adjuvant licensed from Agenus’ wholly owned subsidiary Antigenics.
The approval was based on data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) Phase III vaccine efficacy study.
Arexvy achieved the primary endpoint in the trial by demonstrating a statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in the target group.
Secondary descriptive endpoints demonstrated that efficacy was 94.6% in these subjects with at least one underlying medical condition of interest.
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GSK chief scientific officer Tony Wood stated: “Arexvy is Japan’s first approved RSV older adult vaccine and is a major advance for public health with the potential to help protect around 43.5 million Japanese people aged 60 and older.
“Following key approvals in the US, EU, UK and Canada earlier this year, today’s authorisation reinforces GSK’s industry-leading vaccine portfolio.”
The Arexvy trade name is approved in the US, EU/EEA, UK, Canada and Japan but requires regulatory approval in other markets.
RSV is a contagious virus that affects the lungs and breathing passages.