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
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FDA
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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
325 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 11 | 17 | 41 | 24 | 58 | 146 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 10 | 14 | 34 | 23 | 55 | 132 |
| Kidney transplantation | D016030 | — | — | 5 | 16 | 3 | 6 | 5 | 33 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 1 | 2 | 2 | 5 | 10 |
| Graft rejection | D006084 | — | — | — | 4 | — | 4 | 1 | 9 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 2 | 2 | 3 | 1 | 1 | 8 |
| Renal insufficiency | D051437 | — | N19 | 1 | 1 | 3 | 1 | 1 | 7 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 2 | 1 | 1 | 1 | 5 |
| Delayed graft function | D051799 | — | — | 1 | 1 | — | 2 | 1 | 5 |
| Spondylarthritis | D025241 | — | — | — | 1 | — | 1 | 3 | 5 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 2 | 5 | 1 | — | 1 | 9 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 6 | — | 2 | 8 |
| Leukemia | D007938 | — | C95 | 1 | 5 | 4 | — | — | 7 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 2 | 7 | 1 | — | — | 7 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 5 | 3 | — | — | 6 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | 3 | 4 | — | — | 5 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 3 | 2 | — | — | 5 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | — | 3 | 3 | — | — | 4 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 2 | 2 | 1 | — | — | 4 |
| Nephritis | D009393 | — | N05 | 2 | 2 | 1 | — | — | 4 |
Show 22 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 | 6 | 8 | — | — | — | 10 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 7 | — | — | 1 | 9 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 5 | — | — | — | 5 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 2 | — | — | 1 | 5 |
| Sclerosis | D012598 | — | — | 2 | 3 | — | — | — | 5 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 4 | 2 | — | — | — | 4 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 3 | — | — | 1 | 4 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 3 | — | — | 1 | 4 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | 3 | — | — | — | 3 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | 1 | 2 | — | — | 1 | 3 |
Show 55 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Hepatitis | D006505 | — | K75.9 | 1 | — | — | — | 1 | 2 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | — | — | 1 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | — | — | 1 | 2 |
| Neutropenia | D009503 | — | D70 | 1 | — | — | — | — | 1 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | 1 | — | — | — | — | 1 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 1 | — | — | — | — | 1 |
| Wiskott-aldrich syndrome | D014923 | EFO_0003903 | D82.0 | 1 | — | — | — | — | 1 |
| Hemophagocytic lymphohistiocytosis | D051359 | — | D76.1 | 1 | — | — | — | — | 1 |
| Diamond-blackfan anemia | D029503 | EFO_0004130 | D61.01 | 1 | — | — | — | — | 1 |
Show 18 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 2 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 1 | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 1 | 1 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
Show 29 more
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
CD80
CD80
CD86
CD86
Organism
Homo sapiens
Gene name
CD80
Gene synonyms
CD28LG, CD28LG1, LAB7
NCBI Gene ID
Protein name
T-lymphocyte activation antigen CD80
Protein synonyms
Activation B7-1 antigen, B-lymphocyte activation antigen B7, B7, BB1, CD80, CD80 antigen (CD28 antigen ligand 1, B7-1 antigen), costimulatory factor CD80, costimulatory molecule variant IgV-CD80, CTLA-4 counter-receptor B7.1
Uniprot ID
Mouse ortholog
Cd80 (12519)
T-lymphocyte activation antigen CD80 (Q61332)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Orencia – Bristol Myers Squibb
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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120,851 adverse events reported
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