Arexvy FDA Approval History
Last updated by Judith Stewart, BPharm on June 10, 2024.
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: RSV
Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine used for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus.
- Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:
- individuals 60 years of age and older;
- individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. - 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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