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(Alliance News) - GSK PLC on Tuesday said Japan's Ministry of Health, Labour & Welfare has accepted its regulatory application for the extension of its respiratory syncytial virus vaccine, Arexvy, for adults aged 50-59.
This regulatory submission follows positive results from a phase three trial evaluating the immune response and safety of the RSV vaccine in adults with an increased risk for RSV lower respiratory tract disease as a result of underlying medical conditions.
The Brentford, West London-based pharmaceutical firm said this also follows Japan's approval of GSK's vaccine for the prevention of RSV disease in adults from the age of 60 years in September.
According to GSK, each year, RSV causes approximatively 470,000 hospitalisations and 33,000 in-hospital deaths in adults 60 years of age and older in industrialised countries, including approximately 63,000 hospitalisations and 4,500 deaths in Japan.
GSK said it is the first company to seek regulatory approval to extend RSV vaccination to help protect adults aged 50 to 59 at increased risk for RSV disease.
In May, Arexvy became the first RSV virus vaccine in the world to be approved when the US Food & Drug Administration gave the green light for inoculating older adults.
Further announcements on regulatory progress in the US and EU are expected in early 2024, it added.
Shares in GSK were up 0.8% at 1,459.20 pence each in London on Tuesday morning.
By Sabrina Penty, Alliance News reporter
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