Overview
Nirsevimab (MEDI8897) is a recombinant human immunoglobulin G1 kappa (IgG1ĸ) monoclonal antibody used to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. It binds to the prefusion conformation of the RSV F protein, a glycoprotein involved in the membrane fusion step of the viral entry process, and neutralizes several RSV A and B strains. Compared to palivizumab, another anti-RSV antibody, nirsevimab shows greater potency at reducing pulmonary viral loads in animal models. In addition, nirsevimab was developed as a single-dose treatment for all infants experiencing their first RSV season, whereas palivizumab requires five monthly doses to cover an RSV season. This is due to a modification in the Fc region of nirsevimab that grants it a longer half-time compared to typical monoclonal antibodies. On November 2022, nirsevimab was approved by the EMA for the prevention of RSV lower respiratory tract disease in newborns and infants. Nirsevimab was also approved by Health Canada on April 19, 2023 and by the FDA in July 17, 2023 for the same indication.
Indication
Nirsevimab is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season in Canada, the US, and Europe. Additionally, Nirsevimab is also approved in Canada and the US for use in infants up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. These infants include, but are not limited to, those with chronic lung disease of prematurity, hemodynamically significant congenital heart disease, immunocompromised states, Down syndrome, cystic fibrosis, neuromuscular disease, and congenital airway anomalies.
Associated Conditions
- Lower Respiratory Tract Disease caused by Respiratory Syncytial Virus (RSV)
Research Report
Nirsevimab (Beyfortus®): A Comprehensive Monograph on a Novel Monoclonal Antibody for the Prevention of Respiratory Syncytial Virus Disease
Section 1: Executive Summary
Nirsevimab, marketed as Beyfortus®, represents a transformative advancement in pediatric infectious disease prevention. Developed through a collaboration between AstraZeneca and Sanofi, it is a long-acting monoclonal antibody designed for the passive immunization of infants against Respiratory Syncytial Virus (RSV), the leading cause of lower respiratory tract infections (LRTI) and hospitalization in this vulnerable population.[1] Its novel mechanism of action involves high-affinity binding to a conserved site on the prefusion conformation of the RSV fusion (F) protein, effectively neutralizing the virus before it can infect host cells.[4] A key molecular innovation—a triple amino acid substitution in the Fc region known as the YTE modification—extends the antibody's half-life to approximately 70 days, enabling a single intramuscular dose to provide protection for an entire RSV season.[6] This fundamental feature overcomes the limitations of previous prophylactic options and makes a universal prevention strategy for all infants logistically feasible for the first time.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/10/01 | N/A | Not yet recruiting | |||
2025/08/07 | Not Applicable | Recruiting | |||
2025/08/06 | Not Applicable | Not yet recruiting | Shanghai Institute Of Biological Products | ||
2025/06/27 | Not Applicable | Not yet recruiting | PENTA Foundation | ||
2025/03/04 | N/A | Recruiting | Meyer Children's Hospital IRCCS | ||
2024/08/13 | Phase 4 | Active, not recruiting | |||
2023/12/15 | N/A | Recruiting | |||
2023/09/18 | Phase 3 | Active, not recruiting | |||
2022/06/29 | Phase 3 | Completed | |||
2021/11/05 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sanofi Pasteur Inc. | 49281-574 | INTRAMUSCULAR | 100 mg in 1 mL | 7/17/2023 | |
| Sanofi Pasteur Inc. | 49281-575 | INTRAMUSCULAR | 50 mg in 0.5 mL | 7/17/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/31/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50 MG/ 0.5 ML | SIN17137P | INJECTION, SOLUTION | 50 mg/ 0.5 mL | 11/13/2024 | |
| BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ 1.0 ML | SIN17138P | INJECTION, SOLUTION | 100 mg / 1.0 mL | 11/13/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50MG/0.5ML | N/A | N/A | N/A | 12/13/2024 | |
| BEYFORTUS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/1ML | N/A | N/A | N/A | 12/13/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BEYFORTUS nirsevimab 50mg in 0.5mL solution for injection prefilled syringe | 397898 | Medicine | A | 11/24/2023 | |
| BEYFORTUS nirsevimab 100mg in 1mL solution for injection prefilled syringe | 397899 | Medicine | A | 11/24/2023 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BEYFORTUS 100 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1221689004 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized | |
| BEYFORTUS 50 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1221689001 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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