GSK PLC said on Friday that Japan’s Ministry of Health, Labour & Welfare has approved the expansion of its Arexvy respiratory syncytial virus vaccine to include adults aged 50 to 59 who are at increased risk of severe RSV.
Previously approved in Japan in September 2023 for adults aged 60 and over, the Arexvy vaccine now targets a broader population vulnerable to RSV-related complications such as pneumonia, hospitalization, and death.
GSK, the UK‘s second-largest pharmaceutical firm, highlighted that its RSV vaccine has now been approved for use in adults aged 50-59 at increased risk in 35 countries, including the US, with additional regulatory decisions pending in other regions.
Chief Scientific Officer Tony Wood said: ‘This approval reflects our ambition to protect people at increased risk from the severe consequences of RSV infection. Adults aged 50-59 with certain underlying medical conditions can face debilitating consequences from RSV, so we are pleased to offer those in Japan a vaccine for the first time.’
The approval in Japan comes amid challenges for GSK’s blockbuster Arexvy vaccine, which saw sales drop 72% year-on-year in the third quarter to £188 million. The decline was attributed to stricter US health authority recommendations limiting its use among older and high-risk patients, coupled with a resurgence in Covid-19, which shifted vaccination priorities toward the virus over other immunizations.
Shares in GSK were up 1.1% at 1,323.50 pence each in London on Friday morning.
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