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The European Medicines Agency (EMA) accepted to review GSK’s (NYSE:GSK) application seeking approval of its respiratory syncytial virus (RSV) older adult vaccine candidate.
The British pharma giant on Friday said that the marketing authorisation application (MAA) may be eligible for accelerated assessment if the EMA’s Committee for Medicinal Products for Human Use (CHMP) decides the product is of major interest for public health and therapeutic innovation.
GSK added that a regulatory decision is expected in Q3 2023 and if approved, the vaccine has the potential to be the first vaccine available to help protect older adults from RSV lower respiratory tract disease (LRTD).
The company noted that currently there are no RSV vaccines for older adults approved anywhere in the world.
Earlier this month, the company had also filed with the Japanese regulator for approval of the vaccine.
The MAA was backed by data from a late-stage study, dubbed AReSVi-006, results from which were presented earlier this month.
The trial had evaluated a single dose of GSK’s adjuvanted RSVPreF3 OA ((older adult)) vaccine candidate and showed an overall vaccine efficacy of 82.6% against RSV-LRTD.
The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon adjuvant licensed from Agenus (NASDAQ:AGEN).
GSK +0.95% to $33.03 premarket Oct. 28
