The US Food and Drug Administration (FDA) has accepted for review a supplemental Biologics Licence Application to expand the usage of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 50-59 years.
The vaccine is already in use in the US for individuals aged 60 years and above to prevent RSV-associated lower respiratory tract disease (LRTD).
The application is backed by positive outcomes from a Phase III clinical trial, which assessed the vaccine's immune response and safety in the target age group. These subjects included those with underlying health conditions and hence increased risk for RSV-LRTD.
GSK utilised a Priority Review Voucher to reduce the FDA review period by four months.
A decision on the approval under the Prescription Drug User Fee Act is expected from the FDA on 7 June 2024.
The adjuvanted vaccine contains the RSVPreF3 antigen, a recombinant glycoprotein F stabilised in the prefusion conformation, paired with the company’s AS01E adjuvant.
If approved, Arexvy will become the first vaccine available for RSV prevention in this age group.
The vaccine is also approved in countries, including Japan, Europe, the UK and Canada for RSV-LRTD prevention in people aged 60 years and above.
The European Medicines Agency (EMA) accepted GSK’s regulatory application in January 2024.
GSK has also reported that the China National Medical Products Administration's Center for Drug Evaluation (CDE) is reviewing a regulatory application for Shingrix (recombinant zoster vaccine (RZV)) for shingles prevention in adults.
A non-live, recombinant subunit adjuvanted vaccine, Shingrix received initial approval for use in adults aged 50 years and above in 2019.
The application for the expanded use is based on data from six trials involving patients who have undergone stem cell or kidney transplantation or have blood cancer, a solid tumour or human immunodeficiency virus.
Shingrix combines the glycoprotein E antigen with the AS01B adjuvant system and is designed to overcome the natural decline in immunisation response associated with ageing.
