Pharma Focus Asia

GSK Receives Approval for Arexvy as the First RSV Vaccine for Older Adults

Tuesday, September 26, 2023

GSK has received approval from Japan's Ministry of Health, Labour, and Welfare (MHLW) for Arexvy, a recombinant adjuvanted vaccine designed to protect adults aged 60 years and older from respiratory syncytial virus (RSV) disease.

This milestone marks the first approval of an RSV vaccine for older adults in Japan and has the potential to benefit around 43.5 million individuals in this age group. This approval follows similar authorisations granted earlier this year in the United States, the European Union, the United Kingdom, and Canada.

RSV is a contagious virus that primarily affects the respiratory system, posing a significantly increased risk of severe illness in older adults. RSV can exacerbate pre-existing health conditions such as COPD, asthma, and chronic heart failure, often leading to serious complications like pneumonia, hospitalisation, and even mortality.

Annually, RSV leads to over 470,000 hospitalisations and approximately 33,000 in-hospital deaths among individuals aged 60 and above in developed countries. In Japan alone, this translates to roughly 63,000 hospitalisations and 4,500 fatalities. Adults with underlying medical conditions are more susceptible to seeking medical care and experiencing higher hospitalisation rates compared to those without such conditions.

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