Arexvy FDA Approval History
Last updated by Judith Stewart, BPharm on May 24, 2023.
FDA Approved: Yes (First approved May 3, 2023)
Brand name: Arexvy
Generic name: respiratory syncytial virus vaccine, adjuvanted
Dosage form: Suspension for Intramuscular Injection
Company: GlaxoSmithKline
Treatment for: Prevention of RSV Infection
Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.
- Respiratory syncytial virus (RSV) is a common contagious virus that affects the lungs and breathing passages. It can cause severe disease (pneumonia, hospitalization, and death) in older adults due to age-related declining immunity and/or underlying conditions.
- Arexvy is an adjuvanted vaccine that contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with a proprietary AS01E adjuvant. It works by inducing an immune response against RSVpreF3 that protects against lower respiratory tract disease caused by respiratory syncytial virus.
- Arexvy is administered as a single dose intramuscular injection.
- Common adverse reactions include injection site pain, fatigue, myalgia, headache, and arthralgia.
Development timeline for Arexvy
Further information
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