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GSK RSV vaccine for older adults approved in Japan
GSK RSV vaccine for older adults approved in Japan.
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[{"type":"text","content":"\n\nIssued: 25 September 2023, London UK\n \nJapan's Ministry of Health, Labour and Welfare approves GSK's Arexvy, the country's first respiratory syncytial virus (RSV) vaccine for older adults\n \n· Arexvy's approval will help protect adults 60 years of age and older in Japan from RSV disease for the first time, including those living with underlying medical conditions who are most at risk of severe RSV disease\n· RSV causes an estimated 63,000 hospitalisations and 4,500 in-hospital deaths in adults 60 years of age and older in Japan each year\n· The approval - the first in Asia - is based on a comprehensive phase III programme, which enrolled over 1,000 Japanese participants\n \n\nGSK plc (LSE/NYSE: GSK) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV (respiratory syncytial virus) disease for adults 60 years of age and above. This is the first time an RSV vaccine for older adults has been approved in Japan.\n \nTony Wood, Chief Scientific Officer at GSK, 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[1]. Following key approvals in the US, EU, UK and Canada earlier this year, today's authorisation reinforces GSK's industry-leading vaccine portfolio\".\n \nRSV is a common, contagious respiratory virus[2] that causes an estimated 470,000 hospitalisations and 33,000 deaths each year in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in Japan.[3] Its impact on healthcare systems may further increase as the population ages. Those with underlying medical conditions, such as chronic heart disease, chronic lung disease or diabetes, account for the majority of RSV hospitalisations.[4]\n \nThe approval has been granted based on data from the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III vaccine efficacy trial, published in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2209604). In the trial, the vaccine showed statistically significant and clinically meaningful ov...