Arzerra(ofatumumab)
Arzerra, Kesimpta (ofatumumab) is an antibody pharmaceutical. Ofatumumab was first approved as Arzerra on 2009-10-26. It is used to treat lymphoid leukemia in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia and relapsing-remitting multiple sclerosis. The pharmaceutical is active against B-lymphocyte antigen CD20.
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Novartis Pharmaceuticals
Commercial
Trade Name
FDA
EMA
Arzerra, Kesimpta
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)
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ofatumumab, Arzerra, Novartis Pharmaceuticals Corporation | |||
| 2123-01-19 | Orphan excl. | ||
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FA: Cd20 (clusters of differentiation 20) inhibitors
— L01FA02: Ofatumumab
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA52: Ofatumumab
HCPCS
Code | Description |
|---|---|
| J9302 | Injection, ofatumumab, 10 mg |
Clinical
Clinical Trials
140 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 7 | 32 | 8 | 1 | 1 | 46 | |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | 5 | 4 | 6 | 16 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 3 | 2 | 2 | 7 | 14 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | 5 | 7 | 1 | — | — | 11 | |
| Follicular lymphoma | D008224 | C82 | 2 | 8 | 1 | — | — | 10 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | — | 6 | 1 | — | — | 7 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | 2 | — | — | 4 |
| Leukemia | D007938 | C95 | — | 2 | 1 | — | — | 3 | |
| Pemphigus | D010392 | EFO_1000749 | L10 | — | — | 2 | — | — | 2 |
| Prolymphocytic leukemia t-cell | D015461 | C91.6 | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | — | 6 | — | — | — | 6 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 2 | 4 | — | — | — | 5 | |
| Lymphoma | D008223 | C85.9 | — | 4 | — | — | — | 4 | |
| Burkitt lymphoma | D002051 | C83.7 | — | 3 | — | — | — | 3 | |
| Waldenstrom macroglobulinemia | D008258 | C88.0 | — | 2 | — | — | — | 2 | |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | 2 | — | — | — | 2 |
| Prolymphocytic leukemia | D015463 | 2 | 2 | — | — | — | 2 | ||
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | 1 | 1 | — | — | 1 | 2 |
| Philadelphia chromosome | D010677 | — | 1 | — | — | — | 1 | ||
| Fever | D005334 | HP_0001945 | R50.9 | — | 1 | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic progressive multiple sclerosis | D020528 | — | — | — | — | 1 | 1 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Demyelinating diseases | D003711 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OFATUMUMAB |
| INN | ofatumumab |
| Description | Immunoglobulin G1, anti-(human CD20 (antigen))(human monoclonal HuMax-CD20 heavy chain), disulfide with human monoclonal HuMax-CD20 kappa-chain, dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >3GIZ:H|Fab fragment of anti-CD20 antibody Ofatumumab, heavy chain
EVQLVESGGGLVQPGRSLRLSCAASGFTFNDYAMHWVRQAPGKGLEWVSTISWNSGSIGYADSVKGRFTISRDNAKKSLY
LQMNSLRAEDTALYYCAKDIQYGNYYYGMDVWGQGTTVTVSSASTKGPSVFPLAPGSSKSTSGTAALGCLVKDYFPEPVT
VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEP
>3GIZ:L|Fab fragment of anti-CD20 antibody Ofatumumab, light chain
EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP
EDFAVYYCQQRSNWPITFGQGTRLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNR |
Identifiers
| PDB | 3GIZ, 6Y92 |
| CAS-ID | 679818-59-8 |
| RxCUI | 712566 |
| ChEMBL ID | CHEMBL1201836 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06650 |
| UNII ID | M95KG522R0 (ChemIDplus, GSRS) |
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Kesimpta - Novartis
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Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,707 documents
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Safety
Black-box Warning
Black-box warning for: Arzerra
Adverse Events
Top Adverse Reactions
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28,798 adverse events reported
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