LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) said Friday that a new drug application for its respiratory syncytial virus or RSV older adult vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW).
The proposed indication is for adults aged 60 years and above to prevent lower respiratory tract diseases (LRTD) caused by RSV.
RSV is a common contagious virus affecting the lungs and breathing passages.
The regulatory submission is based on positive pivotal phase III data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above with a favourable safety profile.
Further announcements on regulatory progress in the US and EU are expected in the fourth-quarter 2022. GSK's RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant.
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