Data from EMA (European Medicines Agency) - Curated by Toby Galbraith - Last updated 09 August 2017

Indication(s)

- ORENCIA 250 mg powder for concentrate for solution for infusion

Rheumatoid arthritis
ORENCIA, in combination with methotrexate, is indicated for:
- the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
- the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.

A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.

Psoriatic Arthritis
ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.

Polyarticular juvenile idiopathic arthritis
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other DMARDs including at least one TNF inhibitor.



- ORENCIA 125 mg solution for injection in pre-filled syringe
- ORENCIA 125 mg solution for injection in pre-filled pen


Rheumatoid arthritis
ORENCIA, in combination with methotrexate, is indicated for:
- the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor.
- the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.

A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.

Psoriatic Arthritis
ORENCIA, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required.

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Category Value
Agency product number EMEA/H/C/000701
Orphan designation No
Date First Approved 21-05-2007
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Bristol-Myers Squibb Pharma EEIG