The vaccine’s application is based on the positive findings from a Phase 3 immunogenicity trial that showed an immune response and acceptable tolerability profile in individuals aged 50-59 at increased risk
The US Food and Drug Administration (FDA) has accepted GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine, Arexvy, under priority review in the US to prevent respiratory syncytial virus (RSV) disease in adults aged 50-59 at increased risk.
Arexvy has a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) mixed with the company’s proprietary AS01E adjuvant.
The vaccine is currently approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in patients 60 years of age and older.
If approved, the RSV vaccine will become the first vaccine available to help protect adults aged 50-59 years.
The vaccine’s application is based on the positive findings from a Phase 3 immunogenicity trial.
It assessed the immune response and safety of the vaccine in adults aged 50-59, including patients at increased risk for RSV-LRTD due to core medical conditions.
The results showed an immune response and acceptable tolerability profile in this population.
GSK shortened the four-month US FDA assessment period for a supplemental biologics license application (sBLA) by using a Priority assessment Voucher.
The company said 7 June 2024 is the FDA action date for the regulatory determination under the Prescription Drug User Fee Act.
In a separate development, GSK said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted to review its Shingrix (Recombinant Zoster Vaccine or RZV).
China’s NMPA will assess the regulatory application of Shingrix to prevent shingles (herpes zoster) in adults aged 18 years and over who are at increased risk.
RZV is a non-live, recombinant subunit adjuvanted vaccine, administered intramuscularly in two doses.
Initially, the vaccine was approved in 2019 by the NMPA to prevent shingles in adults aged 50 years and over.
The application is informed by six studies of patients who were 18 years of age or older and had recently undergone kidney transplantation, blood-forming cell transplantation, blood cancer, solid tumour, or HIV.