GSK seeks approval in Japan of GSK 3389245A ,a RSV Vaccine.
The Japan arm of GlaxoSmithKline announced on October 21 that it has filed a new drug application in Japan for its respiratory syncytial virus (RSV) vaccine candidate for the prevention of RSV lower respiratory tract disease (RSV-LRTD) in adults aged 60 years and above
The submission rides on the back of interim analysis results from its multinational PIII clinical study, called AReSVi-006, for adults aged 60 years or older, evaluating the efficacy and safety of the vaccine against RSV-LRTD.
The study was carried out enrolling around 25,000 subjects from 17 countries globally including Japan. Data from the interim analysis demonstrated overall vaccine efficacy against severe LRTD, LRTD in adults aged 70-79 years, LRTD in adults with underlying diseases, and LRTD caused by RSV types A and B.
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