Orencia (abatacept)
- Region
- 🇪🇺 EU
- Active substance
- abatacept
- Company
- Bristol-Myers Squibb Pharma EEIG
- Status
- Authorised
- Therapeutic area
- Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid
- CHMP opinion
- Thu 22 Mar 2007
- EU approval
- Mon 21 May 2007
- Application
- EMEA/H/C/000701
- ATC
- L04AA24
- Official record
- www.ema.europa.eu
Indication
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 (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy. Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
Regulatory milestones
No milestones recorded in the last year.
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