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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
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
urogenital diseasesD000091642
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
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
Crysvitaburosumab-twzaKyowa KirinN-761068 RX2018-04-17
3 products
Labels
FDA
EMA
Brand Name
Status
Last Update
crysvitaBiologic Licensing Application2023-04-11
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
burosumab, Crysvita, Kyowa Kirin, Inc.
2026-09-27Orphan excl.
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BX: Other drugs affecting bone structure and mineralization in atc
— M05BX05: Burosumab
HCPCS
Code
Description
J0584
Injection, burosumab-twza 1 mg
Clinical
Clinical Trials
28 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 ricketsD0530984654218
Rare diseasesD035583———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypophosphatemiaD017674HP_0002148——1——1
Chronic painD059350HP_0012532——1——1
Hypophosphatemic ricketsD063730E83.31——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteomalaciaD010018EFO_1002027M83—1———1
Fibrous dysplasia of boneD005357Orphanet_249M27.8—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBUROSUMAB
INNburosumab
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 classmonoclonal antibodies
Image (chem structure or protein)BUROSUMAB
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB7VEN
CAS-ID1610833-03-8
RxCUI2043855
ChEMBL IDCHEMBL3707326
ChEBI ID—
PubChem CID—
DrugBankDB14012
UNII IDG9WJT6RD29 (ChemIDplus, GSRS)
Target
Agency Approved
FGF23
FGF23
Organism
Homo sapiens
Gene name
FGF23
Gene synonyms
HYPF
NCBI Gene ID
8074
Protein name
fibroblast growth factor 23
Protein synonyms
Phosphatonin, tumor-derived hypophosphatemia inducing factor, Tumor-derived hypophosphatemia-inducing factor
Uniprot ID
Q9GZV9
Mouse ortholog
Fgf23 (64654)
fibroblast growth factor 23 (Q9EPC2)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 413 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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101,500 adverse events reported
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