Drug updated on 4/16/2024
| Dosage Form | Injection (intramuscular; 50 mg/0.5 mL in a single-dose pre-filled syringe) |
| Drug Class | Respiratory syncytial virus (RSV) F protein-directed fusion inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season.
- Indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Summary
- Nirsevimab-alip (Beyfortus) is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates, infants, and children up to 24 months of age who are at risk of severe RSV disease. It has shown significant efficacy in reducing medically attended RSV-related infections and hospitalizations when administered before the RSV season.
- Three studies were reviewed to gather information on Beyfortus' safety and efficacy. These documents compared nirsevimab with other monoclonal antibodies such as palivizumab and motavizumab.
- Compared to placebo, all three drugs - nirsevimab, palivizumab, and motavizumab - significantly reduced RSV-related infections and hospitalizations. Nirsevimab was associated with a reduction rate similar or slightly better than its counterparts without any significant differences in adverse events leading to death or special interest.
- In terms of subgroup considerations for high-risk populations like those born preterm or having chronic lung disease/congenital heart diseases, Beyfortus demonstrated consistent efficacy across various endpoints including very severe cases of RSV infection.
- Pharmacokinetic data from the MEDLEY trial supported that more than 80% of infants belonging to high-risk groups achieved serum exposures at or above predicted efficacious target levels after receiving this medication, which further validates its effectiveness among these subgroups.
- Beyond preventing specific instances directly related to Respiratory Syncytial Virus (RSV), recipients also experienced fewer admissions due to any cause respiratory illness, along with less outpatient visits and antibiotic prescriptions, indicating potential broader healthcare benefits offered by this medication.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Beyfortus (nirsevimab-alip) Prescribing Information. | 2023 | Sanofi Pasteur, Inc., Swiftwater, PA 18370 USA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Nirsevimab for the prevention of respiratory syncytial virus disease in children. Statement of the Spanish Society of Paediatric Infectious Disease (SEIP). | 2023 | Anales de Pediatría |