USA – The US Food and Drug Administration (FDA) has expanded the usage of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine, Arexvy, to include adults aged 50-59 years.
This move comes as part of efforts to combat RSV-associated lower respiratory tract disease (LRTD) in a broader age range.
Currently, Arexvy is approved for individuals aged 60 years and above in the US to prevent RSV-related LRTD.
The application for expansion is supported by positive results from a Phase III clinical trial, which assessed the vaccine’s effectiveness and safety specifically in the target age group.
The trial included individuals with underlying health conditions, who are at increased risk for RSV-LRTD.
GSK used a Priority Review Voucher to expedite the FDA review process by four months.
A decision on the approval is anticipated from the FDA by June 7, 2024, under the Prescription Drug User Fee Act.
Arexvy contains the RSVPreF3 antigen, a recombinant glycoprotein F stabilized in the prefusion conformation, combined with GSK’s AS01E adjuvant.
If approved, Arexvy will be the first vaccine available for RSV prevention in the 50-59 age group.
Notably, Arexvy is already approved in several countries, including Japan, Europe, the UK, and Canada, for RSV-LRTD prevention in individuals aged 60 years and above.
The European Medicines Agency (EMA) accepted GSK’s regulatory application for this expanded usage in January 2024.
Additionally, GSK is seeking approval from the China National Medical Products Administration’s Center for Drug Evaluation (CDE) for Shingrix, a recombinant zoster vaccine (RZV) aimed at preventing shingles in adults.
Shingrix, a non-live, recombinant subunit adjuvanted vaccine, initially received approval for use in adults aged 50 years and above in 2019.
The expanded application for Shingrix is based on data from six trials involving patients who have undergone stem cell or kidney transplantation, or have blood cancer, a solid tumor, or human immunodeficiency virus (HIV).
Shingrix combines the glycoprotein E antigen with the AS01B adjuvant system, designed to address the age-related decline in immunization response.