Overview
Abatacept is a soluble fusion protein, which links the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Structurally, abatacept is a glycosylated fusion protein with a MALDI-MS molecular weight of 92,300 Da and it is a homodimer of two homologous polypeptide chains of 357 amino acids each. It is produced through recombinant DNA technology in mammalian CHO cells. The drug has activity as a selective co-stimulation modulator with inhibitory activity on T lymphocytes. Although approved for the treatment of rheumatoid arthritis, Repligen has entered a slightly different formulation of CTLA4-Ig into clinical trials (RG2077).
Indication
Abatacept is indicated in adult patients for the treatment of moderately-to-severely active rheumatoid arthritis and for the treatment of active psoriatic arthritis. In patients two years of age and older, abatacept is also indicated for the treatment of moderately-to-severely active juvenile idiopathic arthritis. Abatacept is also indicated for the prophylaxis of acute graft-versus-host disease, in combination with methotrexate and a calcineurin inhibitor such as tacrolimus, in patients two years of age and older who are undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.
Associated Conditions
- Acute Graft-Versus-Host Disease (GVHD)
- Moderate to Severe Rheumatoid Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Polyarticular juvenile rheumatoid arthritis, chronic or unspecified
- Psoriatic Arthritis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/15 | Phase 1 | Completed | |||
2024/12/12 | Early Phase 1 | Not yet recruiting | |||
2024/11/12 | Phase 1 | Recruiting | |||
2024/11/08 | Phase 2 | Recruiting | Leland Metheny | ||
2024/10/23 | Phase 3 | Not yet recruiting | |||
2024/05/17 | N/A | Completed | |||
2024/05/01 | Phase 1 | Recruiting | |||
2024/03/12 | Phase 1 | Active, not recruiting | |||
2024/02/28 | Phase 1 | Not yet recruiting | |||
2023/08/24 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| E.R. Squibb & Sons, L.L.C. | 0003-2814 | SUBCUTANEOUS | 50 mg in 0.4 mL | 3/1/2018 | |
| E.R. Squibb & Sons, L.L.C. | 0003-2187 | INTRAVENOUS | 250 mg in 15 mL | 3/1/2018 | |
| E.R. Squibb & Sons, L.L.C. | 0003-2818 | SUBCUTANEOUS | 87.5 mg in 0.7 mL | 3/1/2018 | |
| E.R. Squibb & Sons, L.L.C. | 0003-2188 | SUBCUTANEOUS | 125 mg in 1 mL | 3/1/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/21/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Abatacept Injection | S20200001 | 生物制品 | 注射剂 | 1/8/2020 | |
| Abatacept Injection | 国药准字SJ20200001 | 生物制品 | 注射剂 | 11/27/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ORENCIA abatacept (rch) 125 mg single dose ClickJect prefilled autoinjector | 236039 | Medicine | A | 6/17/2015 | |
| ORENCIA abatacept (rch) 250 mg powder for IV infusion vial | 130100 | Medicine | A | 9/27/2007 | |
| ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection ultrasafe passive needle guard and flange extender | 206764 | Medicine | A | 5/30/2013 | |
| ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection flange extender | 177176 | Medicine | A | 1/4/2012 | |
| ORENCIA abatacept (rch) 125 mg single dose syringe subcutaneous injection needle guard | 177174 | Medicine | A | 1/4/2012 |
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