Beyfortus(nirsevimab)
Beyfortus (nirsevimab) is an antibody pharmaceutical. Nirsevimab was first approved as Beyfortus on 2022-10-31.
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Events Timeline
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FDA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Beyfortus
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Nirsevimab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Beyfortus | nirsevimab-alip | AstraZeneca | N-761328 RX | 2023-07-17 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| beyfortus | Biologic Licensing Application | 2024-08-22 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 1 | 3 | 3 | 1 | 2 | 9 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | 2 | — | 1 | 3 |
| Virus diseases | D014777 | — | B34 | 1 | 1 | 1 | — | — | 2 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 2 | — | — | 2 |
| Communicable diseases | D003141 | — | — | — | 1 | 1 | — | — | 1 |
| Immunization | D007114 | — | — | — | — | 1 | — | — | 1 |
| Healthy volunteers/patients | — | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory syncytial viruses | D012136 | — | — | 2 | — | — | — | 2 | 4 |
| Metapneumovirus | D029121 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis | D001988 | HP_0011950 | — | — | — | — | — | 3 | 3 |
| Viral bronchiolitis | D001990 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nirsevimab |
| INN | nirsevimab |
| Description | Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus (RSV). It is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor that is designed to bind to the fusion protein on the surface of the RSV virus.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1989556-22-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297575 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16258 |
| UNII ID | VRN8S9CW5V (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Beyfortus – AstraZeneca
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 756 documents
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Safety
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Adverse Events
Top Adverse Reactions
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324 adverse events reported
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