The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
GSK Vaccines Headquarters, Belgium. (Credit: GSK plc.)
British pharmaceutical company GSK has received the US Food and Drug Administration (FDA) approval for its adjuvanted respiratory syncytial virus (RSV) vaccine candidate, Arexvy.
Arexvy is an adjuvanted RSV vaccine that contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3), together with GSK’s unique AS01E adjuvant.
The vaccine is indicated for the prevention of lower respiratory tract disease (LRTD) caused by RSV in older people, aged 60 years and above.
GSK licensed QS-21 STIMULON adjuvant, for use in the AS01 adjuvant system, from Antigenics, a subsidiary of US-based biotechnology company Agenus.
Arexvy is the world’s first RSV vaccine to be approved for older adults, said the British drugmaker.
GSK chief scientific officer Tony Wood said: “Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year.
“Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”
The FDA approval is supported by positive data from the GSK’s Phase 3 AReSVi-006 (Adult Respiratory Syncytial Virus) clinical trial.
In the Phase 3 study, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD, meeting the primary endpoint.
The vaccine also showed 94.6% efficacy in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions.
In addition, it showed 94.1% efficacy against severe RSV-LRTD, defined as an RSV-related LRTD episode preventing normal, everyday activities.
The vaccine was generally well tolerated with an acceptable safety profile, with injection site pain, fatigue, myalgia, headache, and arthralgia as the most frequent adverse events.
Last month, the European Medicines Agency (EMA’s) Committee for Medicinal Products for Human Use (CHMP) granted a positive opinion on the vaccine.
Currently regulatory reviews ongoing in Japan and several other countries, with a final European regulatory decision is expected in the coming months.
Furthermore, the Advisory Committee on Immunization Practices (ACIP) is expected to give recommendations on the appropriate use of the vaccine in the US in June this year.