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
186 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 | — | 4 | 10 | 10 | 43 | 67 |
| Sclerosis | D012598 | — | — | — | 4 | 10 | 9 | 37 | 60 |
| Leukemia | D007938 | — | C95 | 9 | 41 | 10 | 1 | 1 | 59 |
| Lymphoid leukemia | D007945 | — | C91 | 9 | 41 | 10 | 1 | 1 | 59 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 9 | 37 | 10 | 1 | 1 | 55 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 3 | 7 | 8 | 15 | 33 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | 1 | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 13 | 40 | 6 | — | — | 53 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 7 | 12 | 1 | — | — | 18 |
| B-cell lymphoma | D016393 | — | — | 3 | 11 | 1 | — | — | 15 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 9 | 1 | — | — | 11 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 8 | 1 | — | — | 9 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 2 | 2 | — | — | 5 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | 2 | 2 | — | — | 5 |
| Pemphigus | D010392 | EFO_1000749 | L10 | — | — | 2 | — | 1 | 3 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | 1 | — | 1 | 2 |
| Prolymphocytic leukemia t-cell | D015461 | — | C91.6 | — | 1 | 1 | — | — | 2 |
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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 | — | 7 | — | — | — | 7 |
| Recurrence | D012008 | — | — | 2 | 3 | — | — | — | 5 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 2 | 4 | — | — | — | 5 |
| Syndrome | D013577 | — | — | — | 3 | — | — | 1 | 4 |
| Burkitt lymphoma | D002051 | — | C83.7 | — | 3 | — | — | — | 3 |
| Hodgkin disease | D006689 | — | C81 | 1 | 2 | — | — | — | 3 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | 2 | — | — | 1 | 3 |
| Nephrosis | D009401 | — | — | — | 2 | — | — | 1 | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | — | — | — | — | 2 | 2 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Demyelinating diseases | D003711 | — | — | — | — | — | — | 1 | 1 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 1 | 1 |
| Optical coherence tomography | D041623 | — | — | — | — | — | — | 1 | 1 |
| Retinal degeneration | D012162 | — | — | — | — | — | — | 1 | 1 |
| Visual acuity | D014792 | — | — | — | — | — | — | 1 | 1 |
| Atrophy | D001284 | — | — | — | — | — | — | 1 | 1 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
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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
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Kesimpta – Novartis
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 6,490 documents
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Safety
Black-box Warning
Black-box warning for: Arzerra
Adverse Events
Top Adverse Reactions
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30,915 adverse events reported
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