ORENCIA
ORENCIA (abatacept) is a selective T cell costimulation modulator used to treat several chronic inflammatory autoimmune conditions and for transplant-related prophylaxis. It is indicated for adults with moderately to severely active rheumatoid arthritis, as well as patients aged two years and older with polyarticular juvenile idiopathic arthritis or active psoriatic arthritis. Additionally, the medication is used in combination with a calcineurin inhibitor and methotrexate to prevent acute graft versus host disease in patients undergoing hematopoietic stem cell transplantation from unrelated donors. Its use is not recommended in combination with other biologic disease-modifying antirheumatic drugs or Janus kinase inhibitors.
How ORENCIA Works
Abatacept functions by inhibiting the activation of T lymphocytes, which are implicated in the pathogenesis of inflammatory diseases like rheumatoid arthritis and psoriatic arthritis. The drug binds to CD80 and CD86, which blocks these molecules from interacting with CD28 on the surface of T cells. This blockade prevents the costimulatory signal necessary for the full activation and proliferation of T cells. By suppressing this immune response, the drug inhibits the production of inflammatory cytokines, including TNF alpha, interferon-γ, and interleukin-2.
Details
- Status
- Prescription
- First Approved
- 2005-12-23
- Routes
- IV (INFUSION)
- Dosage Forms
- INJECTABLE
ORENCIA Approval History
What ORENCIA Treats
4 indicationsORENCIA is approved for 4 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderately to severely active rheumatoid arthritis in adults
- Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
- Active psoriatic arthritis in patients 2 years of age and older
- Prophylaxis of acute graft versus host disease in patients 2 years of age and older undergoing hematopoietic stem cell transplantation
ORENCIA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ORENCIA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ORENCIA is a selective T cell costimulation modulator indicated for: • the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). • the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). • the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). • the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoie...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.