Orencia(abatacept)
Orencia (abatacept) is a protein pharmaceutical. Abatacept was first approved as Orencia on 2005-12-23. It is used to treat juvenile arthritis, psoriatic arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat arthritis, psoriatic arthritis, and rheumatoid arthritis. The pharmaceutical is active against T-lymphocyte activation antigen CD80 and T-lymphocyte activation antigen CD86.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Orencia
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)
Abatacept
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Orencia | abatacept | Bristol Myers Squibb | N-125118 RX | 2005-12-23 | 5 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| orencia | Biologic Licensing Application | 2024-12-13 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
abatacept, Orencia, Bristol-Myers Squibb Company | |||
| 2028-12-15 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0129 | Injection, abatacept, 10 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) |
Clinical
Clinical Trials
322 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 9 | 12 | 25 | 9 | 33 | 84 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | 3 | 5 | 2 | 25 | 34 |
| Kidney transplantation | D016030 | — | — | 1 | 8 | 1 | 3 | 3 | 15 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 1 | 1 | 1 | 3 | 6 |
| Graft rejection | D006084 | — | — | — | 3 | — | 1 | — | 4 |
| Delayed graft function | D051799 | — | — | 1 | 1 | — | 1 | — | 3 |
| Transplantation | D014180 | — | — | 1 | — | — | 1 | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | 1 | 2 |
| Myocarditis | D009205 | — | I51.4 | — | — | 1 | 1 | — | 2 |
| Epstein-barr virus infections | D020031 | EFO_0000769 | — | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 3 | — | 2 | 5 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | 5 | 1 | — | — | 5 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 3 | 2 | — | — | 5 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 1 | — | 1 | — | — | 2 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | 1 | 1 | — | — | 2 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 1 | 1 | — | — | 2 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | 1 | 1 | — | — | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | 1 | — | — | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | 1 | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | — | 1 | — | — | 1 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | 1 | 2 | — | — | — | 3 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 3 | — | — | — | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 1 | — | — | — | 3 |
| Organ transplantation | D016377 | — | — | — | 2 | — | — | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | 2 | — | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 2 | — | — | — | 2 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 2 | — | — | — | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 2 | — | — | — | 2 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | 1 | — | — | — | 1 |
| Proteinuria | D011507 | — | R80 | — | 1 | — | — | — | 1 |
Show 26 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | 1 | — | — | — | — | 1 |
| Vitiligo | D014820 | EFO_0004208 | L80 | 1 | — | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | — | — | — | — | 1 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | 1 | — | — | — | — | 1 |
| Relapsing polychondritis | D011081 | EFO_1001148 | M94.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Islets of langerhans transplantation | D016381 | — | — | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Stem cell transplantation | D033581 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Abatacept |
| INN | abatacept |
| Description | 1-25-oncostatin M (human precursor) fusion protein with CTLA-4 (antigen) (human) fusion protein with immunoglobulin G1 (human heavy chain fragment), bimolecular (146-146')-disulfide |
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: T-cell receptors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201823 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01281 |
| UNII ID | 7D0YB67S97 (ChemIDplus, GSRS) |
Target
Agency Approved
CD86
CD86
Organism
Homo sapiens
Gene name
CD86
Gene synonyms
CD28LG2
NCBI Gene ID
Protein name
T-lymphocyte activation antigen CD86
Protein synonyms
Activation B7-2 antigen, B-lymphocyte activation antigen B7-2, B70, BU63, CD86, CD86 antigen (CD28 antigen ligand 2, B7-2 antigen), CTLA-4 counter-receptor B7.2, FUN-1
Uniprot ID
Mouse ortholog
Cd86 (12524)
T-lymphocyte activation antigen CD86 (P42082)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Orencia – Bristol Myers Squibb
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,157 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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130,991 adverse events reported
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