GCIGSK seeks to extend RSV vaccine approval in Japan
(Sharecast News) - GSK announced on Tuesday that Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted its regulatory application for the extension of the indication of its RSV vaccine to include adults aged 50- to 59 at an increased risk of contracting the disease.
The FTSE 100 pharmaceutical giant said the submission followed the approval of its vaccine for adults aged 60 years and above in the country.
It said positive results from a phase three trial evaluated the immune response and safety of its RSV vaccine in adults aged 50 to 59, including those with underlying medical conditions putting them at risk for RSV lower respiratory tract disease (LRTD).
GSK said it was the first company to seek regulatory approval for extending RSV vaccination to adults aged 50 to 59 at increased risk for RSV disease.
Additional updates on regulatory progress in the United States and the European Union were early next year.
At 0828 GMT, shares in GSK were up 0.76% at 1,458.8p.
Reporting by Josh White for Sharecast.com.
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