The new drug application (NDA) of the single dose adjuvant RSVPreF3 OA vaccine has been reviewed by the Ministry of Health
GlaxoSmithKline (GSK) recently announced that its new drug application (NDA) for the single dose adjuvant RSVPreF3 OA vaccine, a candidate vaccine of respiratory syncytial virus (RSV) for the elderly (OA), has been reviewed by Japan's Ministry of Health, Welfare and Labor (MHLW). The proposed indication is for the elderly aged 60 years and above to prevent lower respiratory tract diseases (LRTD) caused by RSV. GSK expects to further announce regulatory progress in the United States and the European Union by the end of 2022.
RSVPreF3 OA candidate vaccine contains the recombinant subunit fusion pre-RSV F glycoprotein antigen (RSVPreF3) and combines with GSK's proprietary AS01 adjuvant. AS01 has been used in many adjuvant vaccines marketed by GlaxoSmithKline. The combination of antigen and adjuvant may help overcome the natural decline of age related immunity, which helps protect the elderly from the challenge of RSV disease.
This NDA is based on the positive data of the pre designated interim analysis of the critical AReSVi-006 Phase III clinical trial. This test shows that among adults aged 60 years and above, the single dose adjuvant RSVPreF3 OA candidate vaccine against RSV LRTD shows high overall vaccine efficacy and good safety. In addition, consistent high vaccine efficacy against LRTD was observed in severe diseases, adults aged 70-79, adults with underlying comorbidities, and RSV A and B strains.