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Orencia

Abatacept

An intravenous or injectable biological therapy used to treat rheumatoid and psoriatic arthritis.

T-cell costimulation modulator
Generic name
Abatacept
Brand name
Orencia
Route
Intravenous, Subcutaneous
Marketed by
Bristol Myers Squibb
FDA pharmacologic class
Selective T Cell Costimulation Modulator
First FDA approval
23 Dec 2005

Where Abatacept is approved

All regulators →

Of the three regulators tracked here, the first to approve Abatacept was the US, on 23 Dec 2005. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
23 Dec 2005
Orencia
BLA125118 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
21 May 2007
Orencia
EMA product page
First centralised authorisation
CACanada (Health Canada)
29 Jun 2006
Orencia
Notice of Compliance 8083
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Abatacept

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ENNHS England
£3k
3 items dispensed, Aug 2025 to Jul 2026
+150% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$256.7m
58,399 prescriptions in 2025 · Orencia
+8% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Abatacept works

All drug targets →
  • T-lymphocyte activation antigen CD86 inhibitor Inhibitor
    Target: CD86 CD86 molecule
    ✓ In ChEMBL and the Guide to Pharmacology
  • T-lymphocyte activation antigen CD80 inhibitor Inhibitor
    Target: CD80 CD80 molecule
    ✓ In ChEMBL and the Guide to Pharmacology
Other medicines acting on CD86
Other medicines acting on CD80
Diseases it has been tested for in clinical trials, by furthest phase
  • ArthralgiaPhase 3
  • COVID-19Phase 3
  • Crohn diseasePhase 3
  • FatiguePhase 3
  • Sjogren syndromePhase 3
  • Granulomatosis with polyangiitisPhase 3
  • Idiopathic inflammatory myopathyPhase 3
  • Lupus nephritisPhase 3
  • MyocarditisPhase 3
  • Polyarticular juvenile idiopathic arthritisPhase 3
62 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201823, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6891, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

NICE appraisals of Abatacept

All NICE appraisals →

NICE, which decides whether the NHS in England should fund new medicines, has published 8 technology appraisals of Abatacept. 6 are current, and 4 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.

AppraisalNICE recommendationPublishedStatus
Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed
NICE TA715
Optimised Not recommended14 Jul 2021Current
Abatacept for treating psoriatic arthritis after DMARDs (terminated appraisal)
NICE TA568
Terminated (no company submission)13 Mar 2019Current
Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
NICE TA375
Optimised26 Jan 2016Current
Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
NICE TA373
Recommended16 Dec 2015Current
Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
NICE TA195
Optimised Recommended25 Aug 2010Current
Abatacept for the treatment of rheumatoid arthritis
NICE TA141
Not recommended23 Apr 2008Current

NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

Patient leaflets for Abatacept

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 5 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Orencia
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Abatacept

ATC code
L04AA24
ChEMBL
CHEMBL1201823
DrugBank
DB01281
CAS number
332348-12-6
FDA UNII
7D0YB67S97
Wikidata
Q2697833
Wikipedia
Abatacept

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

What Orencia is used for

ORENCIA is a selective T cell costimulation modulator indicated for: • the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1) • the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2) • the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA). (1.3) • 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 hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4) Limitations of Use: Concomitant use of ORENCIA with other immunosuppressives [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not rec…

How it works

12.1 Mechanism of Action Abatacept, a selective costimulation modulator, inhibits T-cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. Activated T lymphocytes are implicated in the pathogenesis of RA, pJIA and PsA and are found in the synovium of patients with RA, pJIA and PsA. In vitro , abatacept decreases T-cell proliferation and inhibits the production of the cytokines TNF alpha (TNFα), interferon-γ, and interleukin-2. In a rat collagen-induced arthritis model, abatacept suppresses inflammation, decreases anti-collagen antibody production, and…

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 6 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.