- MHLW expanded Arexvy approval in Japan to cover adults 18-49 at increased risk for RSV and explicitly includes immunocompromised patients.
- Phase IIIb (NCT06389487) demonstrated a non-inferior immune response in 18-49 AIR versus adults 60+, and Phase IIb (NCT05921903) supported immunocompromised data.
- Arexvy contains recombinant RSVPreF3 antigen stabilized in the prefusion conformation combined with GSK's AS01E adjuvant (includes STIMULON QS-21).
- More than 42 million adults in Japan are aged 18-49, many living with chronic conditions that increase RSV risk.
Regulatory update
Japan’s MHLW expanded Arexvy’s approved population to include adults 18–49 at increased risk for RSV; prior approvals covered all adults 60+ and adults 50–59 at increased risk; prescribing information now explicitly lists immunocompromised patients as an increased-risk group.
Clinical evidence
The approval was supported by a Phase IIIb trial (NCT06389487) showing a non-inferior immune response in 18–49 increased-risk adults versus adults 60+, and by earlier Phase III efficacy data (NCT04886596); data for immunocompromised patients came from a Phase IIb study (NCT05921903).
Safety profile
Safety findings were consistent with the broader Phase III programme, with the most common adverse events being injection-site pain, myalgia, fatigue, arthralgia and headache, typically transient and mild-to-moderate in intensity.
Product details
Arexvy contains recombinant RSVPreF3 antigen stabilised in the prefusion conformation combined with GSK’s AS01E adjuvant, which includes STIMULON QS‑21.
Context
RSV can cause severe illness in adults with chronic conditions, including major adverse cardiovascular events and COPD/asthma exacerbations; more than 42 million Japanese adults are aged 18–49, many living with such conditions; GSK is advancing regulatory submissions in other jurisdictions.
