The antigen is combined with the AS01E adjuvant of GSK. Credit: GSK.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.