(Alliance News) - GSK PLC on Monday said the Japan Ministry of Health, Labour & Welfare has approved Arexvy for adults over 60.
Arexvy is a vaccine used for the prevention of respiratory syncytial virus, which affects the lungs and breathing passages.
This is the first time an RSV vaccine for older adults has been approved in Japan, GSK said. The approval has been granted based on data from the AReSVi-006 phase III vaccine efficacy trial.
According to the London-based pharmaceutical maker, RSV causes approximately 63,000 hospitalisations and 4,500 deaths in Japan every year.
Back in June, Arexvy became the first EU-backed vaccine against the respiratory syncytial virus for adults aged 60 and older after the European Commission authorised the jab, after also receiving approval in the US.
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."
Shares in GSK were up 0.5% at 1,534.60 pence each in London on Monday morning.
By Sabrina Penty, Alliance News reporter
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