Arzerra(ofatumumab)
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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Commercial
Trade Name
FDA
EMA
Kesimpta (discontinued: 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)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| lymphoid leukemia | — | D007945 | C91 |
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
188 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 2 | 7 | 6 | 31 | 46 |
| Sclerosis | D012598 | — | — | — | 1 | 4 | 5 | 21 | 31 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 2 | 6 | 6 | 11 | 25 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 1 | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 3 | 6 | 4 | — | — | 13 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 6 | 4 | — | — | 13 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 4 | 4 | — | — | 11 |
| Lymphoma | D008223 | — | C85.9 | 4 | 6 | 1 | — | — | 10 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 3 | 1 | — | — | 7 |
| Pemphigus | D010392 | EFO_1000749 | L10 | — | — | 1 | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 2 | 2 | — | — | — | 4 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | 1 | — | — | 1 | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
| Optical coherence tomography | D041623 | — | — | — | — | — | — | 1 | 1 |
| Retinal degeneration | D012162 | — | — | — | — | — | — | 1 | 1 |
| Visual acuity | D014792 | — | — | — | — | — | — | 1 | 1 |
| Atrophy | D001284 | — | — | — | — | — | — | 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 | — |
| RxCUI | — |
| 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
No data
Financial
Revenue by drug
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Kesimpta – Novartis
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,094 documents
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Safety
Black-box Warning
Black-box warning for: Arzerra
Adverse Events
Top Adverse Reactions
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35,294 adverse events reported
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