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Beyfortus (NIRSEVIMAB)
BEYFORTUS is a monoclonal antibody that targets RSV.
At a glance
| Generic name | NIRSEVIMAB |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] |
| Target | RSV |
| Modality | Monoclonal antibody |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2023 |
| Annual revenue | 800 |
Mechanism of action
BEYFORTUS works by using a monoclonal antibody to combat Respiratory Syncytial Virus (RSV). This antibody binds to RSV and helps prevent the virus from infecting cells.
Approved indications
- Prevention of respiratory Syncytial Virus (RSV) lower respiratory tract disease
Common side effects
- rash
- injection site reaction
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (PHASE2)
- A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children (PHASE2,PHASE3)
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY) (PHASE3)
- Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China (PHASE3)
- The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products (PHASE4)
- Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India (PHASE4)
- Safety of RSV Preventive Monoclonal Antibody (PHASE4)
- Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Beyfortus CI brief — competitive landscape report
- Beyfortus updates RSS · CI watch RSS
- AstraZeneca portfolio CI