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Hemlibra(emicizumab)
Hemlibra (emicizumab) is an antibody pharmaceutical. Emicizumab was first approved as Hemlibra on 2017-11-16. It is used to treat hemophilia a in the USA. It has been approved in Europe to treat hemophilia a. It is known to target coagulation factor IX and coagulation factor X.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Hemlibra
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)
Emicizumab
Tradename
Proper name
Company
Number
Date
Products
Hemlibraemicizumab-kxwhGenentechN-761083 RX2017-11-16
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
hemlibraBiologic Licensing Application2021-03-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hemophilia aEFO_0007267D006467D66
Agency Specific
FDA
EMA
Expiration
Code
emicizumab, Hemlibra, Genentech, Inc.
2025-10-04Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B02: Antihemorrhagics
— B02B: Vitamin k and other hemostatics
— B02BX: Other systemic hemostatics in atc
— B02BX06: Emicizumab
HCPCS
Code
Description
J7170
Injection, emicizumab-kxwh, 0.5 mg
Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemophilia aD006467EFO_0007267D6622136629
Immune toleranceD007108———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Type 3 von willebrand diseaseD056729Orphanet_166096D68.031————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEMICIZUMAB
INNemicizumab
Description
Emicizumab, sold under the brand name Hemlibra, is a humanized bispecific monoclonal antibody for the treatment of haemophilia A, developed by Genentech and Chugai (a subsidiary of Hoffmann-La Roche). A Phase I clinical trial found that it was well tolerated by healthy subjects.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1610943-06-0
RxCUI1989794
ChEMBL IDCHEMBL3833393
ChEBI ID—
PubChem CID—
DrugBankDB13923
UNII ID7NL2E3F6K3 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
F9
F9
F10
F10
Organism
Homo sapiens
Gene name
F9
Gene synonyms
NCBI Gene ID
2158
Protein name
coagulation factor IX
Protein synonyms
Christmas factor, factor 9, factor IX F9, plasma thromboplastic component, Plasma thromboplastin component, PTC
Uniprot ID
Q5JYJ8
Mouse ortholog
F9 (14071)
coagulation factor IX (P16294)
Variants
Clinical Variant
No data
Financial
Hemlibra - Roche
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 813 documents
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Safety
Black-box Warning
Black-box warning for: Hemlibra
Adverse Events
Top Adverse Reactions
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19 adverse events reported
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