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Orencia FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 16, 2021.

FDA Approved: Yes (First approved December 23, 2005)
Brand name: Orencia
Generic name: abatacept
Dosage form: Injection
Company: Bristol-Myers Squibb Company
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Graft Versus Host Disease - Prophylaxis

Orencia (abatacept) is a selective T cell costimulation modulator indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and the prophylaxis of acute graft versus host disease (aGVHD).

  • Orencia is 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 adult patients 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 hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.
  • Orencia is administered via intravenous infusion or subcutaneous injection.
  • Common adverse reactions in RA are headache, upper respiratory tract infection, nasopharyngitis, and nausea. Common adverse reactions in prophylaxis of aGVHD are anemia, hypertension, CMV reactivation/CMV infection, pyrexia, pneumonia, epistaxis, CD4 lymphocytes decreased, hypermagnesemia, and acute kidney injury.

Development timeline for Orencia

Dec 15, 2021Approval U.S. Food and Drug Administration Approves Orencia (abatacept) in Combination with a Calcineurin Inhibitor and Methotrexate for the Prevention of Acute Graft Versus Host Disease (aGvHD)
Jul  6, 2017Approval Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults
Jul 31, 2011Approval U.S. Food and Drug Administration Approves Subcutaneous Formulation of Orencia (abatacept), a Proven Non-Anti-TNF Biologic for Adults with Moderate to Severe Rheumatoid Arthritis
Dec 23, 2005Approval Orencia Bristol-Myers Squibb Company - Treatment for Rheumatoid Arthritis
Sep  6, 2005Bristol-Myers Squibb Statement on FDA Advisory Committee Vote on Orencia (Abatacept), an Investigational Selective Modulator of T-Cell Co-Stimulation for Rheumatoid Arthritis
Dec 23, 2004Bristol-Myers Squibb Provides Regulatory Update for Abatacept

Further information

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