Simponi - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
golimumab
Post-authorisationHuman
On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Simponi. The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.
The CHMP adopted a new indication as follows:
Paediatric ulcerative colitis (pUC)
Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
For information, the full indications for Simponi will be as follows:
Rheumatoid arthritis (RA)
Simponi, in combination with methotrexate (MTX), is indicated for:
- the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease‑modifying anti‑rheumatic drug (DMARD) therapy including MTX has been inadequate.
- the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX.
Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis (pJIA)
Simponi in combination with MTX is indicated for the treatment of polyarticular juvenile idiopathic arthritis in children 2 years of age and older, who have responded inadequately to previous therapy with MTX.
Psoriatic arthritis (PsA)
Simponi, alone or in combination with MTX, is indicated for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X‑ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Simponi is indicated for the treatment of severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Non‑radiographic axial spondyloarthritis (nr‑Axial SpA)
Simponi is indicated for the treatment of adults with severe, active non‑radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C‑reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Ulcerative colitis (UC)
Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis (pUC)
Simponi is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients 2 years of age and older with a body weight of at least 15 kg, who have had an inadequate response to conventional therapy, including corticosteroids and 6‑mercaptopurine (6‑MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold
CHMP post-authorisation summary of positive opinion for Simponi (II-121)
Adopted
Reference Number: EMA/CHMP/378614/2025
English (EN) (206.94 KB - PDF)
First published: