Beyfortus FDA Approval History
Last updated by Judith Stewart, BPharm on July 17, 2023.
FDA Approved: Yes (First approved July 17, 2023)
Brand name: Beyfortus
Generic name: nirsevimab-alip
Dosage form: Injection
Company: AstraZeneca
Treatment for: RSV
Beyfortus (nirsevimab-alip) is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor used for the prevention of RSV lower respiratory tract disease in neonates and infants.
- Beyfortus is indicated for the prevention of RSV lower respiratory tract disease in:
- neonates and infants born during or entering their first RSV season.
- children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. - RSV is a very contagious virus that can lead to serious respiratory illness in infants. While most infants will experience mild, cold-like symptoms, some will go on to develop more severe lower respiratory tract disease such as pneumonia and bronchiolitis. According to the CDC, two out of three infants are infected with RSV during their first year of life, and almost all infants are infected by their second birthday. In the US, RSV is the leading cause of hospitalisation in infants under 12 months.
- Beyfortus contains nirsevimab-alip, which is a recombinant human IgG1 kappa monoclonal antibody. It works to prevent RSV by binding to the F1 and F2 subunits of the RSV fusion (F) protein to block viral entry into the host cell.
- The safety and efficacy of Beyfortus were supported by three clinical trials (Trials 03, 04 and 05). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI), evaluated during the 150 days after Beyfortus administration. In Trial 03 of preterm infants and Trial 04 of term and late preterm infants, Beyfortus reduced the risk of MA RSV LRTI by approximately 70% and 75% respectively, relative to placebo. Trial 05 was a Synagis-controlled trial that assessed safety and tolerability in preterm infants and and infants with chronic lung disease of prematurity or congenital heart disease, and provided evidence to support the use of Beyfortus to prevent MA RSV LRTI in these patients.
- Beyfortus is administered as a single intramuscular injection, usually in the thigh muscle. If the infant remains at increased risk for RSV, they may receive a second dose in their second RSV season.
- Warnings and precautions associated with Beyfortus include serious hypersensitivity reactions, including anaphylaxis.
- Common adverse reactions include rash and injection site reactions.
Development timeline for Beyfortus
Further information
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