BLAIV (INFUSION)INJECTABLEPriority Review
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
77
Data completeness
4/8 — Partial
Priority Review
ORENCIA (abatacept) by Bristol Myers Squibb. Approved for selective t cell costimulation modulator [epc]. First approved in 2005.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORENCIA (abatacept) is a selective T cell costimulation modulator fusion protein administered intravenously that modulates T cell activation by binding to CD80/CD86 on antigen-presenting cells. It is used to treat autoimmune and inflammatory conditions where T cell-driven immune responses are pathogenic. The drug represents a novel mechanism class distinct from TNF inhibitors and monoclonal antibodies.
$54MPart D
LOE ApproachingAs LOE approaches, brand teams are likely shifting focus to lifecycle management, patient retention programs, and transition planning, with smaller core commercial teams compared to growth-stage products.
Mechanism of Action
Pharmacologic Class:
Selective T Cell Costimulation Modulator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (77)
Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
Started May 2024
41 enrolled
Graft Vs Host DiseaseGraft-versus-host-diseaseGraft Versus Host Disease
Safety and Efficacy of Abatacept for Treating Chronic Cytopenia in Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Haploinsufficiency
Started Nov 2023
0CTLA4 HaploinsufficencyChronic Cytopenia
Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route
Started Oct 2023
330 enrolled
Rheumatoid Arthritis
A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants
Started Aug 2023
174 enrolled
Healthy Participants
Subcutaneous Abatacept in Renal Transplant Recipients
Started Aug 2023
16 enrolled
Kidney Transplant Recipient
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.