The approval was given based on the results from the AReSVi-006 Phase 3 vaccine efficacy trial that enrolled around 25,000 participants from 17 countries
A illustration of respiratory syncytial virus. (Credit: GSK plc.)
GSK has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Arexvy to prevent RSV (respiratory syncytial virus) disease in adults, aged 60 years and above.
Arexvy is an adjuvanted RSV vaccine that contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) along with the GSK’s patented AS01E adjuvant.
The approval claimed to be the first in Asia was given based on the results from the AReSVi-006 Phase 3 vaccine efficacy trial that enrolled around 25,000 participants from 17 countries.
The randomised, placebo-controlled, observer-blind, multi-country study evaluated the efficacy of a single-dose adjuvanted RSVPreF3 vaccine in adults aged 60 years and above.
In the study, the RSV vaccine demonstrated a statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD, which is the primary endpoint.
Additionally, Arexvy showed an overall efficacy of 94.6% in older adults with at least one underlying medical condition of interest.
Furthermore, the vaccine was generally well tolerated, with the most frequently observed solicited adverse events being injection site pain, fatigue, myalgia, headache, and arthralgia in mild to moderate and transient forms.
GSK chief scientific officer Tony Wood said: “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.”
This is the fifth major regulatory approval for Arexvy, following clearance from the European Commission, the US Food and Drug Administration and the regulatory authorities in the UK and Canada.
Last month, the adjuvanted RSV vaccine secured approval from Health Canada to prevent lower respiratory tract disease (LRTD) in individuals 60 years of age and above.