Uplizna(inebilizumab)
Uplizna (inebilizumab) is an antibody pharmaceutical. Inebilizumab was first approved as Uplizna on 2020-06-11. It is used to treat neuromyelitis optica in the USA. It has been approved in Europe to treat neuromyelitis optica. The pharmaceutical is active against B-lymphocyte antigen CD19.
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FDA Novel Drug Approvals 2020
Commercial
Trade Name
FDA
EMA
Uplizna
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)
Inebilizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Uplizna | inebilizumab-cdon | Horizon Therapeutics Public | N-761142 RX | 2020-06-11 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| uplizna | Biologic Licensing Application | 2020-12-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neuromyelitis optica | EFO_0004256 | D009471 | G36.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
inebilizumab, Uplizna, Horizon Therapeutics Ireland DAC | |||
| 2027-06-11 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1823 | Injection, inebilizumab-cdon, 1 mg |
Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 2 | 1 | — | — | 2 |
| Immunoglobulin g4-related disease | D000077733 | — | — | 1 | — | — | 1 | ||
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 1 | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | INEBILIZUMAB |
| INN | inebilizumab |
| Description | Inebilizumab, sold under the brand name Uplizna, is a medication for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1299440-37-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2109334 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12530 |
| UNII ID | 74T7185BMM (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
No data
Variants
Clinical Variant
No data
Financial
Uplizna - Horizon Therapeutics Public
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€
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 437 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,613 adverse events reported
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