Bimzelx is a medicine used to treat the following inflammatory diseases:
- moderate-to-severe plaque psoriasis (red, scaly patches on the skin) in adults who need systemic treatment (treatment with medicines affecting the whole body).
- psoriatic arthritis (inflammation of the joints that often accompanies plaque psoriasis) in adults whose disease does not respond well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot take these medicines. For psoriatic arthritis, Bimzelx is used alone or with
- axial spondyloarthritis (inflammation of the spine causing back pain) in adults whose disease does not respond well enough to conventional treatments. For this condition, it is used in patients who have signs of disease on X-rays (radiographic axial spondyloarthritis) as well as in patients who have clear signs of inflammation but no signs of disease on X-rays (non-radiographic axial spondyloarthritis).
Bimzelx contains the active substance bimekizumab.
Bimzelx : EPAR - Medicine overview (PDF/149.77 KB)
First published: 24/08/2021
Last updated: 15/06/2023
Bimzelx : EPAR - Risk-management-plan summary (PDF/479.91 KB)
First published: 24/08/2021
Last updated: 04/07/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
UCB Pharma S.A.
|Date of issue of marketing authorisation valid throughout the European Union||
Allée de la Recherche 60
09/11/2023 Bimzelx - EMEA/H/C/005316 - IB/0022
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Bimzelx, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Non-radiographic axial spondyloarthritis (nr-axSpA)
Bimzelx is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.