Crysvita(burosumab)
Crysvita (burosumab) is an antibody pharmaceutical. Burosumab was first approved as Crysvita on 2018-02-19. It has been approved in Europe to treat familial hypophosphatemia, hypophosphatemic rickets, osteochondrodysplasias, and osteomalacia. The pharmaceutical is active against fibroblast growth factor 23.
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Commercial
Trade Name
FDA
EMA
Crysvita
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)
Burosumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Crysvita | burosumab-twza | Kyowa Kirin | N-761068 RX | 2018-04-17 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| crysvita | Biologic Licensing Application | 2024-11-01 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
burosumab, Crysvita, Kyowa Kirin, Inc. | |||
| 2026-09-27 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0584 | Injection, burosumab-twza 1 mg |
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Familial hypophosphatemic rickets | D053098 | — | — | 5 | 6 | 8 | 4 | 8 | 28 |
| Hypophosphatemia | D017674 | HP_0002148 | — | 5 | 7 | 6 | 4 | 5 | 24 |
| Osteomalacia | D010018 | EFO_1002027 | M83 | 1 | 2 | 3 | 1 | 3 | 10 |
| Connective tissue neoplasms | D009372 | — | — | — | 2 | — | 1 | 1 | 4 |
| Syndrome | D013577 | — | — | 1 | 2 | — | 1 | — | 4 |
| Sebaceous of jadassohn nevus | D054000 | EFO_1001841 | Q82.5 | 1 | 2 | — | 1 | — | 4 |
| Nevus | D009506 | EFO_0000625 | — | — | 2 | — | 1 | — | 3 |
| Dysplastic nevus syndrome | D004416 | EFO_0004199 | D22 | 1 | — | — | 1 | — | 2 |
| Rare diseases | D035583 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypophosphatemic rickets | D063730 | — | E83.31 | 1 | — | 3 | — | 4 | 8 |
| Rickets | D012279 | HP_0002748 | E55.0 | 1 | — | 3 | — | 4 | 8 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrous dysplasia of bone | D005357 | Orphanet_249 | M27.8 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Craniosynostoses | D003398 | HP_0005458 | Q75.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Burosumab |
| INN | burosumab |
| Description | Burosumab, sold under the brand name Crysvita, is a human monoclonal antibody medication approved 2018 for the treatment of X-linked hypophosphatemia and tumor-induced osteomalacia.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 7VEN |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707326 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14012 |
| UNII ID | G9WJT6RD29 (ChemIDplus, GSRS) |
Target
Agency Approved
FGF23
FGF23
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 641 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,190 adverse events reported
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